Adverse Cardiac Events, Bleeding, Clopidogrel Resistance, Coronary Artery Disease, Coronary Thrombosis, Death, Death From Cardiovascular Disease, Hospitalisations
Conditions
Keywords
CYP2C19 Genotype-guided antiplatelet treatment, Clopidogrel Resistance, Double Antiplatelet Treatment, Chronic Coronary Artery Disease, Implementation of Genotype-guided Medication Treatment, Outcome Study
Brief summary
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug metabolism. The study aimed to answer two research questions: * Does CYP2C19 genotype-guided clopidogrel treatment provide better clinical outcomes when compared with conventional treatment selection led without CYP2C19 genotyping? * Can CYP2C19 genotype-guided antiplatelet treatment be beneficially applied in real-world clinical practice? After obtaining the informed consent eligible study participants screened by inclusion and exclusion criteria were randomized and allocated into two groups: * for whom the CYP2C19 genotype-guided clopidogrel treatment has been applied - the experimental group, * for whom conventional clopidogrel has been applied without CYP2C19 genotyping - the control group. The experimental group participants underwent CYP2C19 genotyping. Study participants with CYP2C19 normal function alleles (NFA) \*2, \*3 genotypes constituted the separate experimental arm and received clopidogrel-based preventive antiplatelet treatment. Participants with CYP2C19 \*2 and \*3 loss of function (LoF) alleles were allocated to the separate experimental group and received preventive antiplatelet treatment alternative to clopidogrel. Study participants who had not undergone CYP2C19 genotyping and received conventional preventive antiplatelet treatment with clopidogrel were assigned as active comparators. All participants in the experimental and comparator groups underwent standard clinical investigations by current guideline recommendations for: * the initial assessment, * follow-up and detection of major adverse cardiovascular events. All patients received the conventional drug treatment by current guideline recommendations for chronic coronary artery disease and comorbid condition management and adverse cardiovascular events prevention. The main research outcome measures include: * evaluating clinical outcomes of CYP2C19 genotype-guided antiplatelet treatment application, * describing models for application of CYP2C19 genotype-guided antiplatelet treatment, * learning about potential access points to the real practice process pipeline for implementation of genotype-guided medication treatment.
Detailed description
The concept of the study is based on current evidence from multiple genetic and clinical studies. At this stage of development preventive treatment of chronic coronary artery disease after ePCI is challenged by risks related to multi-morbidity, recurrent MACCEs and bleeding. Scientific evidence broadly supports pharmacogenetic approaches for routine use of P2Y12 inhibitors (clopidogrel or alternative). Clopidogrel remains the most commonly used P2Y12 inhibitor in the post-ePCI settings. Along with disease-related and co-morbid factors treatment effects are influenced by the variability of the CYP2C19 genotype in the population, which significantly increases the risk of MACCE in loss of function allele (LoF) carriers even with conventional clopidogrel treatment. To improve treatment, a pharmacogenetic expediency model for drug selection is introduced. CYP2C19 allele genotype-guided clopidogrel or an alternative P2Y12 inhibitor treatment is based on robust evidence. The study aimed to learn the comparative benefits of CYP2C19 genotype-guided versus conventional clopidogrel treatment selection applied in real clinical practice for preventing adverse cardiovascular events after ePCI in chronic coronary artery disease. For this purpose, the randomized parallel-group controlled study for CYP2C19 genotype-guided clopidogrel treatment outcomes evaluation for chronic coronary artery disease after the ePCI in real-world practice was conducted. The study addressed research-specific objectives: * forming and random allocating of participants into study arms for CYP2C19 allele genotype-guided versus conventional clopidogrel treatment, * ensuring RT-PCR based assay for CYP2C19 \*2, \*3 LoF alleles detection in randomly selected study participants and forming the experimental study groups, * characterizing clinical traits of study participants and observing adverse clinical events during the 12-month course of study intervention treatment; * evaluating the clinical and non-clinical study outcomes. Following the completion of the informed consent, 283 patients eligible for inclusion and exclusion criteria have been enrolled in the study and randomly allocated into two groups. 83 participants created the control group. They did not undergo CYP2C19 genotyping and received conventional antiplatelet treatment based on clopidogrel. 200 participants were tested for CYP2C19 \*2, \*3 allele genotype. 157 of those who revealed normal CYP2C19 \*2, \*3 allele genotype received conventional preventive antiplatelet treatment based on clopidogrel and created a separate experimental arm. 43 participants who revealed CYP2C19 \*2, \*3 LoF allele genotype required preventive antiplatelet treatment alternative to clopidogrel - based on ticagrelor or prasugrel were allocated into another separate experimental arm and assigned as the perspective arm for further study. Before inclusion, informed consent was obtained from all study participants (or their legal representatives). The randomization and study arm allocation processes were blinded for participants, healthcare teams providing medical care and study outcomes assessors. Nevertheless, after randomization and genetic testing, CYP2C19 allele genotyping results were disclosed to the medical care team and study participants to make ongoing clinical management safe and transparent but remained blinded for study outcomes assessors. RT-PCR-based laboratory assay for CYP2C19 \*2, \*3 alleles genotyping was carried out only once after randomization for each study participant allocated into the experimental group. Tests were performed in the diagnostic laboratory of Vistamedi Ltd served as the central study laboratory. The laboratory test report was provided to the authenticated investigator and as well as participant and entered in the study data report form. Regular healthcare teams conducted clinical management of study participants in a real practice environment including medication treatment under conventional guideline recommendations were detected and initially reported major adverse cardiovascular outcomes, other adverse events, or additional clinical conditions diagnosed or study-related circumstances emerged through the study follow-up period up to the end of the study. Study participants (or their legal representatives) were also allowed to report adverse clinical outcomes, events or emerging circumstances. For a study participant, the expected end of the study is defined as the end date of the 12-month follow-up from the date of the index ePCI. However, in the case of the clinical endpoint which corresponded to and defined the study outcome measure, the date of such endpoint event was determined as the end of the study, even if earlier than 12 months from the index ePCI. The study participant could terminate participation by his or her independent decision, from any time of the research and for any reason, which could or could not be established. Early withdrawal of a participant from the study was considered reasonable if there was repeated non-adherence to the treatment of study interest, rather than sporadic, or when there was preferred to terminate treatment based on the justified best interests of the participant. Clinical outcomes conventionally defined by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the US Food and Drug Administration (FDA), the Academic Research Consortium for High Bleeding Risk (ARC-HBR) and WHO have been measured by clinical endpoints developed over the course of clinical cases. Certain elements of the Coronary Revascularization Outcome Questionnaire (CROQ) and Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure profile were used for measuring of Patient-Reported Outcomes (PROs). Study results were also analyzed using other non-clinical outcome measures that characterized the effectiveness of СYP2C19 genotype-guided P2Y12 inhibitor treatment utilization in real practice. Data from each study participant were entered into a CRF, the form of which was the same for all participants and study centers. Study data are collected, stored, and processed into a custom-designed electronic database. Identifiers, study variables and record data are validated with codes to ensure personal data protection. Personal data, code keys and definitions, and research data are warehoused in separate databases. Only authenticated researchers have access to them. Research data collection centers do not have an internet connection or any other access to the database files. Study data processing is only allowed by the study procedures given in the study protocol. After the data collection, the database containing the personal data of the study participants will be deleted. The de-identified electronic database will be stored after the end of the study for further research purposes for an indefinite period.
Interventions
OTHERCYP2C19 Genotype-Guided Clopidogrel Treatment
Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or an antiplatelet drug (clopidogrel) combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel).
OTHERCYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel
An antiplatelet drug alternative to clopidogrel in conventional dosing regimen, as a component of preventive antiplatelet treatment, such as double antiplatelet treatment (DAPT) with ticagrelor or prasugrel, or prasugrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), or antiplatelet monotherapy (ticagrelor, or prasugrel).
OTHERThe Conventional Clopidogrel Treatment
Clopidogrel as a component of preventive antiplatelet treatment such as double antiplatelet treatment (DAPT), or clopidogrel combined with the non-vitamin K antagonist oral anticoagulants (NOAC), incl. triple antiplatelet treatment (Aspirin, Clopidogrel and a NOAC), or antiplatelet monotherapy (Clopidogrel).
Sponsors
Tbilisi State Medical University
Vistamedi Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
To evaluate CYP2C19 allele genotype-guided clopidogrel treatment outcomes after the ePCI study participants were randomly allocated into parallel study arms. Experimental arm participants have undergone CYP2C19 genotyping. Carriers of normal \*2, \*3 alleles - normal metabolizers phenotype separated as the experimental arm and participants randomly allocated in the comparators arm without CYP2C19 genotyping - the unspecified metabolizers phenotype, have been intervened with clopidogrel-based preventive antiplatelet treatment. Carriers of LoF \*2, \*3 alleles - the poor metabolizers phenotype, have been separated in the experimental arm, assigned as the additional comparators and intervened with preventive antiplatelet treatment alternative to clopidogrel. Clinical and non-clinical outcome measures are expected to be compared between parallel study groups.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with chronic coronary artery disease; * Undergone elective PCI within the last 12 weeks without procedure-related complications; * LVEF≥38% after index PCI; * Completed informed consent form for participation in the study;
Exclusion criteria
* Concomitant using of potent CYP3A4 or CYP2C19 inhibitors; * Morbid obesity, BMI 40 kg/sq.m or more; * Type 1 diabetes mellitus; * Poorly controlled type 2 diabetes mellitus, HbA1c - 9% or more; * Acute Myocardium Infarction; * Coronary artery bypass grafting performed within the last 12 weeks; * Valvular heart disease due to dysplasia, connective tissue disorders or inflammatory disorders, or valvular disorders requiring cardiac surgery; * History of severe hepatic impairment; * Severe chronic kidney disease; * Clinically important leucopenia, lymphopenia, thrombocytopenia or thrombocytosis; * History of hemorrhagic diathesis or coagulopathy; * An active or an obvious threat of bleeding (including GI bleeding): * Bleeding within the past 6 months that required hospitalization; * Blood transfusion during the past 6 months or its refusal; * History of intracranial hemorrhage; * Cardiac or non-cardiac degenerative disease, including: cardiomyopathy, restrictive lung disease, or Neurodegenerative diseases; * Malignant tumor (cancer) that limits life expectancy to less than one year; * Current chemotherapy or immunosuppressive therapy; * Ongoing immunosuppression or immunosuppressive conditions; * Pregnancy or lactation period; * Any disease/condition control of which is not achieved; * Personal (patient/physician dependent) or health care system-related circumstances that can restrict or limit any study procedures or operations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Who Died From Any Cause (Death From Any Cause) | within a 12-month of the study follow-up | The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | within a 12-month of the study follow-up | The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | within a 12-month of the study follow-up | The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | within a 12-month of the study follow-up | The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction as recommended by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | within a 12-month of the study follow-up | The clinical event corresponding to the unstable angina, or angina that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | within a 12-month of the study follow-up | The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions for Stroke and Transient Ischemic Attack during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | within a 12-month of the study follow-up | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 3, 5 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | within a 12-month of the study follow-up | The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 1 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | within a 12-month of the study follow-up | The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. |
| Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | within a 12-month of the study follow-up | The clinical event of any repeated coronary revascularization: percutaneous coronary intervention or coronary artery bypass-grafting detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | within a 12-month of the study follow-up | Net adverse clinical event (NACE) is assessed via measuring and putting together death from any cause, non-fatal myocardial infarction, stroke/TIA, or major bleeding (BARC type 3, 5) as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. |
| The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | within a 12-month of the study follow-up | The number and percentage (%) of study participants treated with a certain antiplatelet drug - aspirin, clopidogrel, P2Y12 inhibitor alternative to clopidogrel, or a non-vitamin K antagonist oral anticoagulant (NOAC) in each study arm |
| Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | within a 12-month of the study follow-up | The number and percentage (%) of each arm of study participants treated with dual antiplatelet treatment, triple antiplatelet treatment, antiplatelet and non-vitamin K antagonist oral anticoagulant combination, or antiplatelet monotherapy |
| Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | within a 12-month of the study follow-up | Major adverse cardiac or cerebral event (MACCE) is assessed by measuring and putting together death from cardiovascular cause, non-fatal myocardial infarction, or stroke/TIA as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event. |
| The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | within a 12-month of the study follow-up | The number and percentage (%) of study participants treated with lipid-lowering medication - statin, or combined statin and ezetimibe, or statin, ezetimibe and PCSK9i in each study arm |
| The Number of Study Cases With Hypoglycemic Medication Prescription | within a 12-month of the study follow-up | The number and percentage (%) of study participants treated with certain hypoglycemic medication - insulin, sodium-glucose cotransporter-2 (SGLT2) inhibitor, metformin, glucagon-like peptide-1 (GLP-1) receptor agonist, or dipeptidyl peptidase IV (DPP IV) inhibitor in each study arm |
| The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | within a 12-month of the study follow-up | The number and percentage (%) of study participants treated with other common evidence-based medication for cardiovascular risk reduction - angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNi), beta adrenergic blocker, loop diuretic, mineralocorticoid receptor antagonist (MCRA), thiazide diuretic, calcium channel blocker, anti-arrhythmic drug or ivabradine in each study arm |
| Number of Study Participants Who Reported Their Health Status as Good or Satisfactory; or With the Appearance of CVD Symptoms; or With a Significant Inability to Self-care (Patient-Reported Health Status) | at 3, 6 and 12-month of the study follow-up | The health status reported by the patient as: a) good or satisfactory; b) with the appearance of CVD symptoms; c) a significant inability to self-care ranked with severity degree of patient well-being, symptom burden, or ability for self-care, which is assessed according to the routine health related quality of life questionnaire definitions. |
| Number of Study Participants Self-reported Angina Not Required Hospitalization (Patient-Reported Angina Not Required Hospitalization) | at 3, 6 and 12-month of the study follow-up | The participant-reported last week episode of chest pain, or any discomfort, shortness of breath, or tightness in the chest due to angina not required hospitalization assessed by the CROQ (Coronary Revascularization Outcome Questionnaire) definitions. |
| Number of Study Participants Reported Last Week's Shortness of Breath Due to Heart Failure Not Requiring Hospitalization (Patient-Reported Heart Failure Severity) | at 3, 6 and 12 months of the study follow-up | The participant reported last week's shortness of breath due to mild physical activity or at rest not requiring hospitalization assessed by the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile definitions. |
Countries
Georgia
Participant flow
Recruitment details
The study investigating CYP2C19 genotype-guided clopidogrel treatment models was conducted by Vistamedi Ltd. (Tbilisi, Georgia) collecting data from out-patient and hospital health care facilities of four clinical cardiology centers in Tbilisi, Georgia. The active recruitment process started after obtaining Institutional Review Boars (IRB) approval of the study protocol and continued for 12 months.
Pre-assignment details
In total, 330 study participants were screened for participation, and 283 who met the study eligibility criteria and signed informed consent forms for study participation were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Normal Metabolizers of Clopidogrel 157 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping and identified as NFA \*2, \*3 carriers. | 157 |
| Passive Metabolizers of Clopidogrel 43 study participants diagnosed with chronic coronary artery disease who had undergone elective PCI, tested with CYP2C19 genotyping, identified as LoF \*2, \*3 alleles carriers. | 43 |
| Unspecified Metabolizers of Clopidogrel 83 participants diagnosed with chronic coronary artery disease who had undergone elective PCI were allocated to the arm through the randomization, without CYP2C19 genotyping and clopidogrel metabolism phenotype have not been specified. | 83 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 | 2 |
| Overall Study | Non-compliance to Treatment | 4 | 1 | 6 |
| Overall Study | Physician Decision | 4 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Normal Metabolizers of Clopidogrel | Total | Unspecified Metabolizers of Clopidogrel | Passive Metabolizers of Clopidogrel |
|---|---|---|---|---|
| Age, Continuous mean age of female study participants | 68.73 years STANDARD_DEVIATION 7.15 | 68.57 years STANDARD_DEVIATION 7.33 | 67.80 years STANDARD_DEVIATION 8.05 | 69.25 years STANDARD_DEVIATION 6.96 |
| Age, Continuous mean age of male study participants | 61.24 years STANDARD_DEVIATION 8.88 | 61.52 years STANDARD_DEVIATION 9.06 | 61.06 years STANDARD_DEVIATION 10.18 | 63.83 years STANDARD_DEVIATION 6.84 |
| Age, Continuous mean age of overall study participants | 63.91 years STANDARD_DEVIATION 9.03 | 64.16 years STANDARD_DEVIATION 9.1 | 63.49 years STANDARD_DEVIATION 9.96 | 66.35 years STANDARD_DEVIATION 7.34 |
| Age, Customized Age ranges of study participants 35-49 years old | 13 Participants | 21 Participants | 8 Participants | 0 Participants |
| Age, Customized Age ranges of study participants 50-64 years old | 62 Participants | 112 Participants | 33 Participants | 17 Participants |
| Age, Customized Age ranges of study participants 65-79 years old | 82 Participants | 150 Participants | 42 Participants | 26 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Carotid Artery Disease with endarterectomy | 4 Participants | 12 Participants | 8 Participants | 0 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Carotid Artery Disease with endarterectomy and stenting | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Carotid Artery Disease without intravascular intervention | 36 Participants | 67 Participants | 22 Participants | 9 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Carotid Artery Disease with stenting | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Cerebrovascular Disease with minor stroke | 14 Participants | 16 Participants | 0 Participants | 2 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Cerebrovascular Disease with TIA | 51 Participants | 96 Participants | 30 Participants | 15 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Peripheral Artery Disease with endarterectomy | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Peripheral Artery Disease with endarterectomy and stenting | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Peripheral Artery Disease without intravascular intervention | 15 Participants | 31 Participants | 9 Participants | 7 Participants |
| Atherosclerotic vascular co-morbid diseases/conditions Peripheral Artery Disease with stenting | 6 Participants | 19 Participants | 11 Participants | 2 Participants |
| Blood Pressure control 35-49 years old study participants with Controlled BP | 8 Participants | 13 Participants | 5 Participants | 0 Participants |
| Blood Pressure control 35-49 years old study participants with Uncontrolled BP | 5 Participants | 8 Participants | 3 Participants | 0 Participants |
| Blood Pressure control 50-64 years old study participants with Controlled BP | 34 Participants | 53 Participants | 8 Participants | 11 Participants |
| Blood Pressure control 50-64 years old study participants with Uncontrolled BP | 28 Participants | 59 Participants | 25 Participants | 6 Participants |
| Blood Pressure control 65-79 years old study participants with Controlled BP | 47 Participants | 72 Participants | 8 Participants | 17 Participants |
| Blood Pressure control 65-79 years old study participants with Uncontrolled BP | 35 Participants | 78 Participants | 34 Participants | 9 Participants |
| Blood Pressure control Female study participants with Controlled BP | 31 Participants | 51 Participants | 7 Participants | 13 Participants |
| Blood Pressure control Female study participants with Uncontrolled BP | 25 Participants | 55 Participants | 23 Participants | 7 Participants |
| Blood Pressure control Male study participants with Controlled BP | 58 Participants | 87 Participants | 14 Participants | 15 Participants |
| Blood Pressure control Male study participants with Uncontrolled BP | 43 Participants | 90 Participants | 39 Participants | 8 Participants |
| Blood Pressure control Overall study participants with Controlled BP | 89 Participants | 138 Participants | 21 Participants | 28 Participants |
| Blood Pressure control Overall study participants with Uncontrolled BP | 68 Participants | 145 Participants | 62 Participants | 15 Participants |
| Body Mass Index (BMI) of study participants 35-49 years old study participants | 30.2 kg/m^2 STANDARD_DEVIATION 4.69 | 30.7 kg/m^2 STANDARD_DEVIATION 4.3 | 31.6 kg/m^2 STANDARD_DEVIATION 3.7 | — |
| Body Mass Index (BMI) of study participants 50-64 years old study participants | 31.3 kg/m^2 STANDARD_DEVIATION 4 | 31.00 kg/m^2 STANDARD_DEVIATION 3.9 | 30.6 kg/m^2 STANDARD_DEVIATION 2.9 | 30.8 kg/m^2 STANDARD_DEVIATION 5.2 |
| Body Mass Index (BMI) of study participants 65-79 years old study participants | 29.9 kg/m^2 STANDARD_DEVIATION 4.46 | 30.3 kg/m^2 STANDARD_DEVIATION 4.37 | 31.1 kg/m^2 STANDARD_DEVIATION 4.18 | 30.3 kg/m^2 STANDARD_DEVIATION 4.38 |
| Body Mass Index (BMI) of study participants Female study participants | 30.2 kg/m^2 STANDARD_DEVIATION 4.62 | 30.7 kg/m^2 STANDARD_DEVIATION 4.31 | 31.7 kg/m^2 STANDARD_DEVIATION 3.12 | 30.5 kg/m^2 STANDARD_DEVIATION 4.88 |
| Body Mass Index (BMI) of study participants Male study participants | 30.6 kg/m^2 STANDARD_DEVIATION 4.17 | 30.6 kg/m^2 STANDARD_DEVIATION 4.12 | 30.57 kg/m^2 STANDARD_DEVIATION 3.89 | 30.5 kg/m^2 STANDARD_DEVIATION 4.58 |
| Body Mass Index (BMI) of study participants Overall study participants | 30.5 kg/m^2 STANDARD_DEVIATION 4.32 | 30.6 kg/m^2 STANDARD_DEVIATION 4.18 | 31.0 kg/m^2 STANDARD_DEVIATION 3.65 | 30.5 kg/m^2 STANDARD_DEVIATION 4.67 |
| BP measurement results of study participants DBP of 35-49 years old study participants | 83.8 mmHg STANDARD_DEVIATION 10.34 | 83.7 mmHg STANDARD_DEVIATION 10.9 | 83.5 mmHg STANDARD_DEVIATION 12.5 | — |
| BP measurement results of study participants DBP of 50-64 years old study participants | 83.3 mmHg STANDARD_DEVIATION 13.51 | 85.2 mmHg STANDARD_DEVIATION 13.22 | 91.3 mmHg STANDARD_DEVIATION 10.74 | 80.5 mmHg STANDARD_DEVIATION 12.97 |
| BP measurement results of study participants DBP of 65-79 years old study participants | 81.5 mmHg STANDARD_DEVIATION 11.45 | 83.1 mmHg STANDARD_DEVIATION 11.67 | 88.8 mmHg STANDARD_DEVIATION 9.71 | 79.1 mmHg STANDARD_DEVIATION 12.32 |
| BP measurement results of study participants DBP of female study participants | 82.7 mmHg STANDARD_DEVIATION 11.75 | 83.6 mmHg STANDARD_DEVIATION 11.97 | 88.6 mmHg STANDARD_DEVIATION 10.2 | 78.7 mmHg STANDARD_DEVIATION 12.89 |
| BP measurement results of study participants DBP of male study participant | 82.2 mmHg STANDARD_DEVIATION 12.47 | 84.2 mmHg STANDARD_DEVIATION 12.44 | 89.7 mmHg STANDARD_DEVIATION 10.77 | 80.4 mmHg STANDARD_DEVIATION 12.28 |
| BP measurement results of study participants DBP of overall study participants | 82.4 mmHg STANDARD_DEVIATION 12.19 | 84.0 mmHg STANDARD_DEVIATION 12.25 | 89.3 mmHg STANDARD_DEVIATION 10.52 | 79.6 mmHg STANDARD_DEVIATION 12.45 |
| BP measurement results of study participants SBP of 35-49 years old study participants | 129.5 mmHg STANDARD_DEVIATION 12.61 | 131.6 mmHg STANDARD_DEVIATION 13.62 | 135.0 mmHg STANDARD_DEVIATION 15.34 | — |
| BP measurement results of study participants SBP of 50-64 years old study participant | 139.9 mmHg STANDARD_DEVIATION 21.55 | 142.1 mmHg STANDARD_DEVIATION 20.55 | 150.4 mmHg STANDARD_DEVIATION 16.16 | 133.7 mmHg STANDARD_DEVIATION 20.01 |
| BP measurement results of study participants SBP of 65-79 years old study participants | 138.0 mmHg STANDARD_DEVIATION 22.31 | 140.8 mmHg STANDARD_DEVIATION 20.98 | 150.5 mmHg STANDARD_DEVIATION 15.59 | 134.3 mmHg STANDARD_DEVIATION 19.68 |
| BP measurement results of study participants SBP of female study participants | 139.1 mmHg STANDARD_DEVIATION 22.64 | 141.6 mmHg STANDARD_DEVIATION 21.47 | 150.1 mmHg STANDARD_DEVIATION 17.84 | 135.9 mmHg STANDARD_DEVIATION 20.27 |
| BP measurement results of study participants SBP of male study participants | 137.5 mmHg STANDARD_DEVIATION 20.83 | 140.1 mmHg STANDARD_DEVIATION 19.88 | 148.3 mmHg STANDARD_DEVIATION 15.45 | 132.5 mmHg STANDARD_DEVIATION 19.26 |
| BP measurement results of study participants SBP of overall study participants | 138.1 mmHg STANDARD_DEVIATION 21.44 | 140.7 mmHg STANDARD_DEVIATION 20.47 | 149.0 mmHg STANDARD_DEVIATION 16.27 | 134.1 mmHg STANDARD_DEVIATION 19.57 |
| Coronary Artery Anatomy 1st diagonal branch of the left anterior descending coronary artery : Non-obstructive | 30 Participants | 54 Participants | 17 Participants | 7 Participants |
| Coronary Artery Anatomy 1st diagonal branch of the left anterior descending coronary artery : Obstructive | 56 Participants | 97 Participants | 29 Participants | 12 Participants |
| Coronary Artery Anatomy 1st Marginal arteries : Non-obstructive | 39 Participants | 82 Participants | 29 Participants | 14 Participants |
| Coronary Artery Anatomy 1st Marginal arteries : Obstructive | 40 Participants | 73 Participants | 24 Participants | 9 Participants |
| Coronary Artery Anatomy 2nd diagonal branch of the left anterior descending coronary artery : Non-obstructive | 9 Participants | 18 Participants | 7 Participants | 2 Participants |
| Coronary Artery Anatomy 2nd diagonal branch of the left anterior descending coronary artery : Obstructive | 4 Participants | 9 Participants | 3 Participants | 2 Participants |
| Coronary Artery Anatomy 2nd Marginal arteries : Non-obstructive | 7 Participants | 10 Participants | 3 Participants | 0 Participants |
| Coronary Artery Anatomy 2nd Marginal arteries : Obstructive | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Coronary Artery Anatomy Left anterior descending artery : Non-obstructive | 15 Participants | 31 Participants | 11 Participants | 5 Participants |
| Coronary Artery Anatomy Left anterior descending artery : Obstructive | 105 Participants | 187 Participants | 52 Participants | 30 Participants |
| Coronary Artery Anatomy Left circumflex artery : Non-obstructive | 26 Participants | 55 Participants | 17 Participants | 12 Participants |
| Coronary Artery Anatomy Left circumflex artery : Obstructive | 104 Participants | 183 Participants | 53 Participants | 26 Participants |
| Coronary Artery Anatomy Left main coronary artery : Non-obstructive | 6 Participants | 13 Participants | 4 Participants | 3 Participants |
| Coronary Artery Anatomy Left main coronary artery : Obstructive | 5 Participants | 5 Participants | 0 Participants | 0 Participants |
| Coronary Artery Anatomy Posterior descending artery : Non-obstructive | 13 Participants | 23 Participants | 8 Participants | 2 Participants |
| Coronary Artery Anatomy Posterior descending artery : Obstructive | 12 Participants | 29 Participants | 15 Participants | 2 Participants |
| Coronary Artery Anatomy Right coronary artery : Non-obstructive | 44 Participants | 84 Participants | 25 Participants | 15 Participants |
| Coronary Artery Anatomy Right coronary artery : Obstructive | 75 Participants | 129 Participants | 34 Participants | 20 Participants |
| Coronary Artery Anatomy Right marginal branch of right coronary artery : Non-obstructive | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Coronary Artery Anatomy Right marginal branch of right coronary artery : Obstructive | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Coronary artery bypass grafting | 21 Participants | 33 Participants | 7 Participants | 5 Participants |
| Coronary Artery Lesion Number of Haemodynamically Significant Coronary Artery Lesion Sites | 2.53 Coronary artery lesions STANDARD_DEVIATION 1.21 | 2.49 Coronary artery lesions STANDARD_DEVIATION 1.14 | 2.54 Coronary artery lesions STANDARD_DEVIATION 1.1 | 2.23 Coronary artery lesions STANDARD_DEVIATION 0.95 |
| Coronary Artery Lesion Total Number of Coronary Artery Lesion Sites | 4.01 Coronary artery lesions STANDARD_DEVIATION 1.1 | 4.01 Coronary artery lesions STANDARD_DEVIATION 1.1 | 4.17 Coronary artery lesions STANDARD_DEVIATION 1.09 | 3.79 Coronary artery lesions STANDARD_DEVIATION 1.13 |
| Doppler- echocardiographic characteristics Aortic valve calcification | 27 Participants | 58 Participants | 23 Participants | 8 Participants |
| Doppler- echocardiographic characteristics Increased left ventricular filling pressure | 23 Participants | 47 Participants | 18 Participants | 6 Participants |
| Doppler- echocardiographic characteristics Left ventricular hypertrophy | 115 Participants | 217 Participants | 68 Participants | 34 Participants |
| Doppler- echocardiographic characteristics Mitral annular calcification (MAC) | 9 Participants | 21 Participants | 9 Participants | 3 Participants |
| Doppler- echocardiographic characteristics Right Ventricular Dilatation | 20 Participants | 45 Participants | 20 Participants | 5 Participants |
| Doppler- echocardiographic characteristics Secondary (functional) aortic regurgitation | 24 Participants | 82 Participants | 41 Participants | 17 Participants |
| Doppler- echocardiographic characteristics Secondary (functional) mitral regurgitation | 123 Participants | 228 Participants | 69 Participants | 36 Participants |
| Doppler- echocardiographic characteristics Secondary (functional) tricuspid regurgitation | 67 Participants | 106 Participants | 18 Participants | 21 Participants |
| Echocardiographic Linear Dimensions Interventricular septum thickness | 12.04 millimeter STANDARD_DEVIATION 1.33 | 12.15 millimeter STANDARD_DEVIATION 1.49 | 12.49 millimeter STANDARD_DEVIATION 1.84 | 11.88 millimeter STANDARD_DEVIATION 1.14 |
| Echocardiographic Linear Dimensions Left atrium transverse diameter | 42.51 millimeter STANDARD_DEVIATION 5.87 | 42.22 millimeter STANDARD_DEVIATION 5.5 | 41.36 millimeter STANDARD_DEVIATION 5.37 | 42.84 millimeter STANDARD_DEVIATION 4.07 |
| Echocardiographic Linear Dimensions Left ventricular end-diastolic diameter | 49.64 millimeter STANDARD_DEVIATION 5.49 | 49.62 millimeter STANDARD_DEVIATION 5.27 | 50.41 millimeter STANDARD_DEVIATION 4.58 | 48.02 millimeter STANDARD_DEVIATION 4.07 |
| Echocardiographic Linear Dimensions Left ventricular posterior wall thickness | 11.45 millimeter STANDARD_DEVIATION 1.22 | 11.46 millimeter STANDARD_DEVIATION 1.86 | 11.54 millimeter STANDARD_DEVIATION 1.73 | 11.30 millimeter STANDARD_DEVIATION 1.01 |
| Glycated Hemoglobin (HbA1c) Levels 35-49 years old study participants | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.07 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.07 | 6.2 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.11 | — |
| Glycated Hemoglobin (HbA1c) Levels 50-64 years old study participants | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.05 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.06 | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.13 | 6.1 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.97 |
| Glycated Hemoglobin (HbA1c) Levels 65-79 years old study participants | 6.2 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.83 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.98 | 6.7 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.15 | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.01 |
| Glycated Hemoglobin (HbA1c) Levels Female study participants | 6.1 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.78 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.02 | 6.6 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.23 | 6.7 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.12 |
| Glycated Hemoglobin (HbA1c) Levels Male study participants | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.01 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.95 | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.08 | 6.0 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.78 |
| Glycated Hemoglobin (HbA1c) Levels Overall study participants | 6.3 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 0.94 | 6.4 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.01 | 6.5 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.13 | 6.3 percentage (%) of glycated hemoglobin STANDARD_DEVIATION 1.01 |
| History of Cardiovascular Morbidity Atrial Fibrillation - Paroxysmal | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| History of Cardiovascular Morbidity Atrial Fibrillation - Permanent | 5 Participants | 11 Participants | 4 Participants | 2 Participants |
| History of Cardiovascular Morbidity Atrial Fibrillation - Persistent | 23 Participants | 34 Participants | 5 Participants | 6 Participants |
| History of Cardiovascular Morbidity AV Block | 10 Participants | 13 Participants | 3 Participants | 0 Participants |
| History of Cardiovascular Morbidity Bight Bundle Branch Block | 40 Participants | 81 Participants | 23 Participants | 18 Participants |
| History of Cardiovascular Morbidity Chronic Heart Failure | 50 Participants | 92 Participants | 29 Participants | 13 Participants |
| History of Cardiovascular Morbidity Left Bundle Branch Block | 19 Participants | 40 Participants | 17 Participants | 4 Participants |
| History of Cardiovascular Morbidity Premature Ventricular Contraction | 135 Participants | 250 Participants | 80 Participants | 35 Participants |
| History of Cardiovascular Morbidity Prior Myocardium Infarction | 83 Participants | 144 Participants | 40 Participants | 21 Participants |
| History of Cardiovascular Morbidity Sinus Node Disfunction | 4 Participants | 6 Participants | 1 Participants | 1 Participants |
| History of Cardiovascular Morbidity Supraventricular tachycardia - paroxysmal | 29 Participants | 37 Participants | 2 Participants | 6 Participants |
| History of Cardiovascular Morbidity Supraventricular tachycardia - paroxysmal, recurrent | 6 Participants | 10 Participants | 0 Participants | 4 Participants |
| History of Cardiovascular Morbidity Ventricular Fibrillation Event | 8 Participants | 9 Participants | 1 Participants | 0 Participants |
| History of Cardiovascular Morbidity Ventricular Tachycardia | 25 Participants | 34 Participants | 4 Participants | 5 Participants |
| Intracoronary Stenting History | 2.17 number of stents STANDARD_DEVIATION 0.88 | 2.20 number of stents STANDARD_DEVIATION 0.89 | 2.33 number of stents STANDARD_DEVIATION 0.98 | 2.09 number of stents STANDARD_DEVIATION 0.72 |
| Left Atrium Volume Index | 37.45 millilitre per square meter (ml/m^2) STANDARD_DEVIATION 5.89 | 37.32 millilitre per square meter (ml/m^2) STANDARD_DEVIATION 5.73 | 37.47 millilitre per square meter (ml/m^2) STANDARD_DEVIATION 5.41 | 36.56 millilitre per square meter (ml/m^2) STANDARD_DEVIATION 5.86 |
| Left Ventricular Ejection Fraction | 54.39 portion of volume in percent (%) STANDARD_DEVIATION 6.32 | 53.79 portion of volume in percent (%) STANDARD_DEVIATION 6.23 | 52.13 portion of volume in percent (%) STANDARD_DEVIATION 6.12 | 54.77 portion of volume in percent (%) STANDARD_DEVIATION 5.58 |
| Left Ventricular Mass Index | 112.40 gram per square meter (g/m^2) STANDARD_DEVIATION 22.08 | 113.01 gram per square meter (g/m^2) STANDARD_DEVIATION 24.18 | 115.59 gram per square meter (g/m^2) STANDARD_DEVIATION 27.9 | 110.26 gram per square meter (g/m^2) STANDARD_DEVIATION 23.92 |
| Left Ventricular Relative Wall Thickness | 0.48 proportion in hundredths STANDARD_DEVIATION 0.07 | 0.48 proportion in hundredths STANDARD_DEVIATION 0.07 | 0.48 proportion in hundredths STANDARD_DEVIATION 0.08 | 0.49 proportion in hundredths STANDARD_DEVIATION 0.06 |
| Left Ventricular Volume Index | 64.87 milliliter per square meter (ml/m^2) STANDARD_DEVIATION 20.53 | 61.64 milliliter per square meter (ml/m^2) STANDARD_DEVIATION 18.19 | 56.04 milliliter per square meter (ml/m^2) STANDARD_DEVIATION 10.58 | 60.70 milliliter per square meter (ml/m^2) STANDARD_DEVIATION 18.35 |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 35-49 years old study participants Controlled LDL-C Level | 4 Participants | 8 Participants | 4 Participants | 0 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 35-49 years old study participants Uncontrolled LDL-C Level | 9 Participants | 13 Participants | 4 Participants | 0 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 50-64 years old study participants Controlled LDL-C Level | 29 Participants | 45 Participants | 4 Participants | 12 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 50-64 years old study participants Uncontrolled LDL-C Level | 33 Participants | 67 Participants | 29 Participants | 5 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 65-79 years old study participants Controlled LDL-C Level | 32 Participants | 49 Participants | 4 Participants | 13 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status 65-79 years old study participants Uncontrolled LDL-C Level | 50 Participants | 101 Participants | 38 Participants | 13 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Female study participants Controlled LDL-C Level | 24 Participants | 39 Participants | 2 Participants | 13 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Female study participants Uncontrolled LDL-C Level | 32 Participants | 67 Participants | 28 Participants | 7 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Male study participants Controlled LDL-C Level | 41 Participants | 63 Participants | 10 Participants | 12 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Male study participants Uncontrolled LDL-C Level | 60 Participants | 114 Participants | 43 Participants | 11 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Overall study participants Controlled LDL-C Level | 65 Participants | 102 Participants | 12 Participants | 25 Participants |
| Low Density Lipoprotein Cholesterol (LDL-C) Controlling Status Overall study participants Uncontrolled LDL-C Level | 92 Participants | 181 Participants | 71 Participants | 18 Participants |
| Major Coronary Vascular Event Number of PCIs | 1.55 number of events STANDARD_DEVIATION 0.58 | 1.61 number of events STANDARD_DEVIATION 0.64 | 1.75 number of events STANDARD_DEVIATION 0.71 | 1.56 number of events STANDARD_DEVIATION 0.67 |
| Major Coronary Vascular Event Number of Prior MI events | 0.53 number of events STANDARD_DEVIATION 0.51 | 0.53 number of events STANDARD_DEVIATION 0.53 | 0.55 number of events STANDARD_DEVIATION 0.63 | 0.49 number of events STANDARD_DEVIATION 0.51 |
| Obesity among study participants 35-49 years study participants | 7 Participants | 13 Participants | 6 Participants | 0 Participants |
| Obesity among study participants 50-64 years old study participants | 53 Participants | 78 Participants | 17 Participants | 8 Participants |
| Obesity among study participants 65-79 years old study participants | 41 Participants | 79 Participants | 25 Participants | 13 Participants |
| Obesity among study participants Female study participants | 31 Participants | 63 Participants | 22 Participants | 10 Participants |
| Obesity among study participants Male study participants | 60 Participants | 97 Participants | 26 Participants | 11 Participants |
| Obesity among study participants Overall study participants | 91 Participants | 160 Participants | 48 Participants | 21 Participants |
| Other co-morbid diseases/conditions Chronic Gastritis | 59 Participants | 107 Participants | 30 Participants | 18 Participants |
| Other co-morbid diseases/conditions Chronic Kidney Disease | 36 Participants | 70 Participants | 26 Participants | 8 Participants |
| Other co-morbid diseases/conditions Chronic Obstructive Pulmonary Disease | 55 Participants | 94 Participants | 26 Participants | 13 Participants |
| Other co-morbid diseases/conditions Cured Cancer | 14 Participants | 27 Participants | 8 Participants | 5 Participants |
| Other co-morbid diseases/conditions GI Bleeding Event | 7 Participants | 15 Participants | 6 Participants | 2 Participants |
| Other co-morbid diseases/conditions Peptic Ulcer | 21 Participants | 44 Participants | 12 Participants | 11 Participants |
| Other co-morbid diseases/conditions Thyroid Disease | 25 Participants | 38 Participants | 5 Participants | 8 Participants |
| Pulmonary Artery Systolic Pressure | 38.22 millimetres of mercury (mmHg) STANDARD_DEVIATION 8.67 | 37.47 millimetres of mercury (mmHg) STANDARD_DEVIATION 8.21 | 36.47 millimetres of mercury (mmHg) STANDARD_DEVIATION 7.77 | 36.67 millimetres of mercury (mmHg) STANDARD_DEVIATION 7.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 157 Participants | 283 Participants | 83 Participants | 43 Participants |
| Region of Enrollment Georgia | 157 Participants | 283 Participants | 83 Participants | 43 Participants |
| Serum LDL-C measurement results 35-49 years old study participants | 99.5 mg/dl STANDARD_DEVIATION 57.12 | 98.0 mg/dl STANDARD_DEVIATION 55.03 | 95.6 mg/dl STANDARD_DEVIATION 55.01 | — |
| Serum LDL-C measurement results 50-64 years old study participants | 95.0 mg/dl STANDARD_DEVIATION 53.93 | 98.1 mg/dl STANDARD_DEVIATION 49.93 | 118.3 mg/dl STANDARD_DEVIATION 34.45 | 70.3 mg/dl STANDARD_DEVIATION 46.2 |
| Serum LDL-C measurement results 65-79 years old study participants | 93.5 mg/dl STANDARD_DEVIATION 49.47 | 99.3 mg/dl STANDARD_DEVIATION 45.54 | 121.0 mg/dl STANDARD_DEVIATION 31.29 | 82.4 mg/dl STANDARD_DEVIATION 40.26 |
| Serum LDL-C measurement results Female study participants | 91.8 mg/dl STANDARD_DEVIATION 48.85 | 96.2 mg/dl STANDARD_DEVIATION 44.59 | 119.9 mg/dl STANDARD_DEVIATION 25.49 | 73.2 mg/dl STANDARD_DEVIATION 39.87 |
| Serum LDL-C measurement results Male study participants | 96.1 mg/dl STANDARD_DEVIATION 53.23 | 100.2 mg/dl STANDARD_DEVIATION 49.8 | 116.1 mg/dl STANDARD_DEVIATION 40.33 | 81.4 mg/dl STANDARD_DEVIATION 45.35 |
| Serum LDL-C measurement results Overall study participants | 94.6 mg/dl STANDARD_DEVIATION 51.59 | 98.7 mg/dl STANDARD_DEVIATION 47.87 | 117.5 mg/dl STANDARD_DEVIATION 35.56 | 77.6 mg/dl STANDARD_DEVIATION 42.59 |
| Sex: Female, Male Female | 56 Participants | 106 Participants | 30 Participants | 20 Participants |
| Sex: Female, Male Male | 101 Participants | 177 Participants | 53 Participants | 23 Participants |
| Smoking status of study participants 35-49 years old study participants Current Smoker | 8 Participants | 15 Participants | 7 Participants | 0 Participants |
| Smoking status of study participants 35-49 years old study participants Former Smoker | 4 Participants | 5 Participants | 1 Participants | 0 Participants |
| Smoking status of study participants 35-49 years old study participants Never Smoker | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Smoking status of study participants 50-64 years old study participants Current Smoker | 34 Participants | 71 Participants | 29 Participants | 8 Participants |
| Smoking status of study participants 50-64 years old study participants Former Smoker | 20 Participants | 30 Participants | 3 Participants | 7 Participants |
| Smoking status of study participants 50-64 years old study participants Never Smoker | 8 Participants | 11 Participants | 1 Participants | 2 Participants |
| Smoking status of study participants 65-79 years old study participants Current Smoker | 16 Participants | 36 Participants | 14 Participants | 6 Participants |
| Smoking status of study participants 65-79 years old study participants Former Smoker | 33 Participants | 52 Participants | 10 Participants | 9 Participants |
| Smoking status of study participants 65-79 years old study participants Never Smoker | 33 Participants | 62 Participants | 18 Participants | 11 Participants |
| Smoking status of study participants Female study participants Current Smoker | 7 Participants | 15 Participants | 7 Participants | 1 Participants |
| Smoking status of study participants Female study participants Former Smoker | 12 Participants | 23 Participants | 5 Participants | 6 Participants |
| Smoking status of study participants Female study participants Never Smoker | 37 Participants | 68 Participants | 18 Participants | 13 Participants |
| Smoking status of study participants Male study participants Current Smoker | 51 Participants | 107 Participants | 43 Participants | 13 Participants |
| Smoking status of study participants Male study participants Former Smoker | 45 Participants | 64 Participants | 9 Participants | 10 Participants |
| Smoking status of study participants Male study participants Never Smoker | 5 Participants | 6 Participants | 1 Participants | 0 Participants |
| Smoking status of study participants Overall study participants Current Smoker | 58 Participants | 122 Participants | 50 Participants | 14 Participants |
| Smoking status of study participants Overall study participants Former Smoker | 57 Participants | 87 Participants | 14 Participants | 16 Participants |
| Smoking status of study participants Overall study participants Never Smoker | 42 Participants | 74 Participants | 19 Participants | 13 Participants |
| Symptom manifestations/conditions prior to index PCI Angina | 107 Participants | 211 Participants | 76 Participants | 28 Participants |
| Symptom manifestations/conditions prior to index PCI Atrial Fibrillation | 7 Participants | 9 Participants | 0 Participants | 2 Participants |
| Symptom manifestations/conditions prior to index PCI Heart Failure Event | 22 Participants | 32 Participants | 5 Participants | 5 Participants |
| Symptom manifestations/conditions prior to index PCI Left Bundle Branch Block | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Symptom manifestations/conditions prior to index PCI No angina | 50 Participants | 72 Participants | 7 Participants | 15 Participants |
| Symptom manifestations/conditions prior to index PCI Other non-specific symptoms | 13 Participants | 19 Participants | 1 Participants | 5 Participants |
| Symptom manifestations/conditions prior to index PCI Premature Ventricular Contraction/Ventricular tachycardia | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Symptom manifestations/conditions prior to index PCI Supraventricular Tachycardia | 5 Participants | 8 Participants | 1 Participants | 2 Participants |
| Tricuspid Annular Plane Systolic Excursion | 21.03 millimeters STANDARD_DEVIATION 2.77 | 20.95 millimeters STANDARD_DEVIATION 2.67 | 20.83 millimeters STANDARD_DEVIATION 2.21 | 20.88 millimeters STANDARD_DEVIATION 3.12 |
| Type 2 Diabetes Mellitus 35-49 years old study participants Controlled T2DM | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Type 2 Diabetes Mellitus 35-49 years old study participants No T2DM | 7 Participants | 12 Participants | 5 Participants | 0 Participants |
| Type 2 Diabetes Mellitus 35-49 years old study participants Uncontrolled T2DM | 6 Participants | 8 Participants | 2 Participants | 0 Participants |
| Type 2 Diabetes Mellitus 40-64 years old study participants Controlled T2DM | 12 Participants | 15 Participants | 2 Participants | 1 Participants |
| Type 2 Diabetes Mellitus 40-64 years old study participants No T2DM | 24 Participants | 51 Participants | 16 Participants | 11 Participants |
| Type 2 Diabetes Mellitus 40-64 years old study participants Uncontrolled T2DM | 26 Participants | 46 Participants | 15 Participants | 5 Participants |
| Type 2 Diabetes Mellitus 65-79 years old study participants Controlled T2DM | 18 Participants | 25 Participants | 0 Participants | 7 Participants |
| Type 2 Diabetes Mellitus 65-79 years old study participants No T2DM | 37 Participants | 64 Participants | 19 Participants | 8 Participants |
| Type 2 Diabetes Mellitus 65-79 years old study participants Uncontrolled T2DM | 27 Participants | 61 Participants | 23 Participants | 11 Participants |
| Type 2 Diabetes Mellitus Female study participants Controlled T2DM | 15 Participants | 20 Participants | 1 Participants | 4 Participants |
| Type 2 Diabetes Mellitus Female study participants No T2DM | 25 Participants | 44 Participants | 13 Participants | 6 Participants |
| Type 2 Diabetes Mellitus Female study participants Uncontrolled T2DM | 16 Participants | 42 Participants | 16 Participants | 10 Participants |
| Type 2 Diabetes Mellitus Male study participants Controlled T2DM | 15 Participants | 21 Participants | 2 Participants | 4 Participants |
| Type 2 Diabetes Mellitus Male study participants No T2DM | 43 Participants | 83 Participants | 27 Participants | 13 Participants |
| Type 2 Diabetes Mellitus Male study participants Uncontrolled T2DM | 43 Participants | 73 Participants | 24 Participants | 6 Participants |
| Type 2 Diabetes Mellitus Overall study participants Controlled T2DM | 30 Participants | 41 Participants | 3 Participants | 8 Participants |
| Type 2 Diabetes Mellitus Overall study participants No T2DM | 68 Participants | 127 Participants | 40 Participants | 19 Participants |
| Type 2 Diabetes Mellitus Overall study participants Uncontrolled T2DM | 59 Participants | 115 Participants | 40 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 142 | 2 / 38 | 7 / 70 |
| other Total, other adverse events | 4 / 142 | 4 / 38 | 5 / 70 |
| serious Total, serious adverse events | 23 / 142 | 10 / 38 | 25 / 70 |
Outcome results
Primary
Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause)
The event of death from any cardiovascular cause reported by the physician according the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | 5 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | 1 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cardiovascular Cause (Death From Cardiovascular Cause) | 6 Participants |
Primary
Number of Study Participants Who Died From Any Cause (Death From Any Cause)
The event of death from any cause reported by the physician according to the WHO Clinical criteria for the determination of death or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cause (Death From Any Cause) | 8 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cause (Death From Any Cause) | 2 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Died From Any Cause (Death From Any Cause) | 7 Participants |
Primary
Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause)
The event of death from a non-cardiovascular cause reported by the physician or the incident declared by the caregiver of the patient and checked for appropriateness in hospital registries or the national death registry within the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | 3 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | 1 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Died From Non-cardiovascular Causes (Death From Non-cardiovascular Cause) | 1 Participants |
Secondary
Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA)
The clinical event of the stroke or transitory ischemic attack detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions for Stroke and Transient Ischemic Attack during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | 5 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | 1 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced a Stroke or Transitory Cerebral Ischemic Event Within the Study Follow-up Period (Stroke or TIA) | 3 Participants |
Secondary
Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event)
The clinical event of heart failure that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | 14 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | 4 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Heart Failure Event (Heart Failure Event) | 9 Participants |
Secondary
Number of Study Participants Who Experienced Major Bleeding (Major Bleeding)
The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 3, 5 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | 3 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | 2 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Major Bleeding (Major Bleeding) | 4 Participants |
Secondary
Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction)
The clinical event of the non-fatal myocardial infarction detected during the study follow-up period and assessed by the 2012 Third Universal Definition of Myocardial Infarction as recommended by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | 4 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | 1 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-fatal Myocardial Infarction (Non-fatal Myocardial Infarction) | 4 Participants |
Secondary
Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding)
The clinical event of major bleeding detected during the study follow-up period and assessed by the ARC-HBR (Academic Research Consortium for High Bleeding Risk) definitions as BARC type 1 of bleeding during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | 2 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | 4 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Non-major Bleeding (Non-major Bleeding) | 4 Participants |
Secondary
Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization)
The clinical event of any repeated coronary revascularization: percutaneous coronary intervention or coronary artery bypass-grafting detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | 17 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | 4 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Percutaneous Coronary Intervention or Coronary Artery Bypass-grafting (Repeated Coronary Revascularization) | 16 Participants |
Secondary
Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina)
The clinical event corresponding to the unstable angina, or angina that requires hospitalization detected during the study follow-up period and assessed by the SCTI (Standardized Data Collection for Cardiovascular Trials Initiative) definitions during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | 14 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | 3 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Participants Who Experienced Unstable Angina or Angina Requiring Hospitalization (Unstable Angina) | 16 Participants |
Other Pre-specified
Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs)
Net adverse clinical event (NACE) is assessed via measuring and putting together death from any cause, non-fatal myocardial infarction, stroke/TIA, or major bleeding (BARC type 3, 5) as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | 20 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | 6 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases in Each Arm With a Composite of Death From Any Cause, Non-fatal Myocardial Infarction, Stroke/TIA, or Major Bleeding Within the Study Follow-up (Net Adverse Clinical Events - NACEs) | 18 Participants |
Other Pre-specified
Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs)
Major adverse cardiac or cerebral event (MACCE) is assessed by measuring and putting together death from cardiovascular cause, non-fatal myocardial infarction, or stroke/TIA as potential outcomes for every studied case during the study follow-up period, from the date of study enrollment until the date of the event.
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | 17 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | 4 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases in Each Study Arm With a Composite of Death From Any Cause, Myocardial Infarction, or Stroke/TIA Within the Study Follow-up (Major Adverse Cardiac or Cerebral Events - MACCEs) | 14 Participants |
Other Pre-specified
Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm
The number and percentage (%) of each arm of study participants treated with dual antiplatelet treatment, triple antiplatelet treatment, antiplatelet and non-vitamin K antagonist oral anticoagulant combination, or antiplatelet monotherapy
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Antiplatelet monotherapy | 7 Participants |
| Normal Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Combined antiplatelet and non-vitamin K antagonist oral anticoagulant (NOAC) | 14 Participants |
| Normal Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Triple antiplatelet treatment | 22 Participants |
| Normal Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Dual Antiplatelet Treatment (DAPT) | 114 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Dual Antiplatelet Treatment (DAPT) | 27 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Triple antiplatelet treatment | 0 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Combined antiplatelet and non-vitamin K antagonist oral anticoagulant (NOAC) | 10 Participants |
| Passive Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Antiplatelet monotherapy | 6 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Triple antiplatelet treatment | 11 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Dual Antiplatelet Treatment (DAPT) | 72 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Antiplatelet monotherapy | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | Number of Study Cases With Certain Antiplatelet Treatment Selection (Dual Antiplatelet Treatment, Triple Antiplatelet Treatment, Combined Antiplatelet and Anticoagulant, or Antiplatelet Monotherapy) in Each Study Arm | Combined antiplatelet and non-vitamin K antagonist oral anticoagulant (NOAC) | 0 Participants |
Other Pre-specified
Number of Study Participants Reported Last Week's Shortness of Breath Due to Heart Failure Not Requiring Hospitalization (Patient-Reported Heart Failure Severity)
The participant reported last week's shortness of breath due to mild physical activity or at rest not requiring hospitalization assessed by the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile definitions.
Time frame: at 3, 6 and 12 months of the study follow-up
Other Pre-specified
Number of Study Participants Self-reported Angina Not Required Hospitalization (Patient-Reported Angina Not Required Hospitalization)
The participant-reported last week episode of chest pain, or any discomfort, shortness of breath, or tightness in the chest due to angina not required hospitalization assessed by the CROQ (Coronary Revascularization Outcome Questionnaire) definitions.
Time frame: at 3, 6 and 12-month of the study follow-up
Other Pre-specified
Number of Study Participants Who Reported Their Health Status as Good or Satisfactory; or With the Appearance of CVD Symptoms; or With a Significant Inability to Self-care (Patient-Reported Health Status)
The health status reported by the patient as: a) good or satisfactory; b) with the appearance of CVD symptoms; c) a significant inability to self-care ranked with severity degree of patient well-being, symptom burden, or ability for self-care, which is assessed according to the routine health related quality of life questionnaire definitions.
Time frame: at 3, 6 and 12-month of the study follow-up
Other Pre-specified
The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription
The number and percentage (%) of study participants treated with a certain antiplatelet drug - aspirin, clopidogrel, P2Y12 inhibitor alternative to clopidogrel, or a non-vitamin K antagonist oral anticoagulant (NOAC) in each study arm
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Aspirin | 136 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Clopidogrel | 157 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | P2Y12 inhibitor, alternative to Clopidogrel | 0 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Non-vitamin K antagonist oral anticoagulant (NOAC) | 36 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Non-vitamin K antagonist oral anticoagulant (NOAC) | 10 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Aspirin | 32 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | P2Y12 inhibitor, alternative to Clopidogrel | 38 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Clopidogrel | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Non-vitamin K antagonist oral anticoagulant (NOAC) | 11 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Clopidogrel | 83 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | P2Y12 inhibitor, alternative to Clopidogrel | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Certain Antiplatelet Medication (Aspirin, Clopidogrel, P2Y12 Inhibitor, Alternative to Clopidogrel, or A Non-vitamin K Antagonist Oral Anticoagulant (NOAC)) Prescription | Aspirin | 83 Participants |
Other Pre-specified
The Number of Study Cases With Hypoglycemic Medication Prescription
The number and percentage (%) of study participants treated with certain hypoglycemic medication - insulin, sodium-glucose cotransporter-2 (SGLT2) inhibitor, metformin, glucagon-like peptide-1 (GLP-1) receptor agonist, or dipeptidyl peptidase IV (DPP IV) inhibitor in each study arm
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Glucagon-like peptide-1 (GLP-1) receptor agonist | 3 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Metformin | 39 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Dipeptidyl peptidase IV (DPP IV) inhibitor | 31 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Sodium-glucose cotransporter-2 (SGLT2) inhibitor | 81 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Insulin | 4 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Insulin | 2 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Sodium-glucose cotransporter-2 (SGLT2) inhibitor | 23 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Metformin | 12 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Glucagon-like peptide-1 (GLP-1) receptor agonist | 0 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Dipeptidyl peptidase IV (DPP IV) inhibitor | 10 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Dipeptidyl peptidase IV (DPP IV) inhibitor | 30 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Glucagon-like peptide-1 (GLP-1) receptor agonist | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Insulin | 4 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Metformin | 31 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Hypoglycemic Medication Prescription | Sodium-glucose cotransporter-2 (SGLT2) inhibitor | 43 Participants |
Other Pre-specified
The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription
The number and percentage (%) of study participants treated with lipid-lowering medication - statin, or combined statin and ezetimibe, or statin, ezetimibe and PCSK9i in each study arm
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin, ezetimibe and PCSK9i | 3 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin and ezetimibe | 67 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Statin | 87 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin, ezetimibe and PCSK9i | 0 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Statin | 27 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin and ezetimibe | 16 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin, ezetimibe and PCSK9i | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Combined statin and ezetimibe | 62 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Lipid-lowering Medication (Statin, or Combination With Ezetimibe, or Ezetimibe and PCSK9i) Prescription | Statin | 21 Participants |
Other Pre-specified
The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction
The number and percentage (%) of study participants treated with other common evidence-based medication for cardiovascular risk reduction - angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNi), beta adrenergic blocker, loop diuretic, mineralocorticoid receptor antagonist (MCRA), thiazide diuretic, calcium channel blocker, anti-arrhythmic drug or ivabradine in each study arm
Time frame: within a 12-month of the study follow-up
Population: Study participants of both sexes aged 35-79 years old, diagnosed with chronic coronary artery disease, who had undergone elective PCI and required P2Y12 inhibitor antiplatelet treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin converting enzyme inhibitor (ACEi) | 47 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor neprilysin Inhibitor (ARNi) | 21 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Beta adrenergic blocker | 129 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Loop diuretic | 43 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Mineralocorticoid receptor antagonist (MCRA) | 47 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Thiazide diuretic | 32 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Calcium channel blocker | 58 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Anti-arrhythmic drug | 22 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Ivabradine | 4 Participants |
| Normal Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor blocker (ARB) | 83 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Ivabradine | 1 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Loop diuretic | 8 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Mineralocorticoid receptor antagonist (MCRA) | 15 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Calcium channel blocker | 13 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Thiazide diuretic | 5 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin converting enzyme inhibitor (ACEi) | 13 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor blocker (ARB) | 22 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Anti-arrhythmic drug | 11 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor neprilysin Inhibitor (ARNi) | 7 Participants |
| Passive Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Beta adrenergic blocker | 34 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Anti-arrhythmic drug | 3 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Beta adrenergic blocker | 80 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Loop diuretic | 31 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Ivabradine | 0 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Mineralocorticoid receptor antagonist (MCRA) | 26 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor blocker (ARB) | 24 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Thiazide diuretic | 37 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin converting enzyme inhibitor (ACEi) | 51 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Angiotensin receptor neprilysin Inhibitor (ARNi) | 20 Participants |
| Unspecified Metabolizers of Clopidogrel | The Number of Study Cases With Other Common Evidence-Based Medication Prescription for Cardiovascular Risk Reduction | Calcium channel blocker | 32 Participants |