Cardiovascular Disease, Myocardial Infarction
Conditions
Keywords
Polypill, Prevention of Secondary Cardiovascular Disease, Cardiovascular Disease, Myocardial Infarction, Cardiovascular Combination Polypill AAR, Cardiovascular Disease in the Elderly, Adherence, SECURE, Elderly, Secondary Cardiovascular Disease, Secondary Cardiovascular Prevention, Randomized Cardiovascular Trial, Randomized Trial, Cardiovascular Polypill
Brief summary
The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.
Detailed description
A total number of 2499 patients have been randomized (1:1) to treatment arms. Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic). Patients will be ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment. Once the inclusion and exclusion criteria are confirmed, patients will be included in the study after signing informed consent. Randomization will take place within 6 months of the index event (AMI type I) in a 1:1 ratio to one of the two arms: * Cardiovascular Polypill (containing Aspirin, Ramipril, and Atorvastatin) * Usual care Patients will be followed up for a minimum of 2 years and a maximum of 5 years. There will be 3 follow up visits at month 6, 12 and 24 and telephone follow up calls at month 18, 36, 48 and 60
Interventions
DRUGCardiovascular Polypill
Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
DRUGTreatment Prevention for Secondary CV
ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
Sponsors
Charite University, Berlin, Germany
Centre Hospitalier Universitaire de Besancon
Wroclaw Medical University
Semmelweis University
General University Hospital, Prague
Servicio Madrileño de Salud, Madrid, Spain
London School of Hygiene and Tropical Medicine
Ferrer Internacional S.A.
Istituto Di Ricerche Farmacologiche Mario Negri
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with a type 1 myocardial infarction within the previous 6 months. 2. Subjects must be ≥65 years old, presenting with at least one of the following additional conditions: * Documented diabetes mellitus or previous treatment with oral hypoglycemic drugs or insulin. * Mild to moderate renal dysfunction: creatinine clearance 60-30 mL/min/1.73 m2. * Prior myocardial infarction: defined as an AMI occurring before the index event documented in a medical report. * Prior coronary revascularization: coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). * Prior stroke: history of a documented stroke, defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, not resulting in death. * Age ≥ 75 years. 3. Signing informed consent.
Exclusion criteria
1. Unable to sign informed consent. 2. Contraindications to any of the components of the polypill. 3. Living in a nursing home. 4. Mental illness limiting the capacity of self-care. 5. Participating in another clinical trial. 6. Severe congestive heart failure (NYHA III-IV). 7. Severe renal disease (Creatinine Clearance (CrCl) \<30ml/min/1.73 m2). 8. Need for oral anticoagulation at the time of randomization or planned in the future months. 9. Any condition limiting life expectancy \<2 years, including but not limited to active malignancy. 10. Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation). 11. Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the prespecified timeframe). 12. Do not agree to the filing, forwarding and use of his/ her pseudonymised data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Adverse Events (MACE) | Up to 5 years | The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoints | 6 months | Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. |
| Safety Endpoints | Up to 5 Years | All-cause mortality. |
Countries
Czechia, France, Germany, Hungary, Italy, Poland, Spain
Participant flow
Recruitment details
Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic). Patients were ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment.
Pre-assignment details
Patients can be screened at any time within the first 8 weeks after index event (type 1 myocardial infarction) whenever they are clinically stable and ready to receive secondary prevention therapy, including the hospital phase. Patients with ventricular arrhythmias needing further evaluation of therapy.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Prevention for Secondary CV Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..
Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention. | 1,229 |
| Cardiovascular Polypill Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.
Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.
Participants will receive one of the following cardiovascular polypill:
(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
or
(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). | 1,237 |
| Total | 2,466 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 21 |
| Overall Study | Protocol Violation | 7 | 9 |
Baseline characteristics
| Characteristic | Total | Cardiovascular Polypill | Treatment Prevention for Secondary CV |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2466 Participants | 1237 Participants | 1229 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants | 13 Participants | 18 Participants |
| Race (NIH/OMB) White | 2432 Participants | 1221 Participants | 1211 Participants |
| Region of Enrollment Czechia | 172 participants | 85 participants | 87 participants |
| Region of Enrollment France | 144 participants | 74 participants | 70 participants |
| Region of Enrollment Germany | 366 participants | 182 participants | 184 participants |
| Region of Enrollment Hungary | 90 participants | 45 participants | 45 participants |
| Region of Enrollment Italy | 731 participants | 366 participants | 365 participants |
| Region of Enrollment Poland | 123 participants | 63 participants | 60 participants |
| Region of Enrollment Spain | 840 participants | 422 participants | 418 participants |
| Sex: Female, Male Female | 765 Participants | 384 Participants | 381 Participants |
| Sex: Female, Male Male | 1701 Participants | 853 Participants | 848 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 117 / 1,229 | 115 / 1,237 |
| other Total, other adverse events | 388 / 1,229 | 404 / 1,237 |
| serious Total, serious adverse events | 220 / 1,229 | 248 / 1,237 |
Outcome results
Primary
Major Cardiovascular Adverse Events (MACE)
The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Major Cardiovascular Adverse Events (MACE) | 156 number of adjudicated events |
| Cardiovascular Polypill | Major Cardiovascular Adverse Events (MACE) | 118 number of adjudicated events |
p-value: <0.02595% CI: [0.6, 0.96]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | Low adherence (0-5) | 9.5 percentage of participants |
| Treatment Prevention for Secondary CV | Efficacy Endpoints | Medium adherence (6-7) | 27.8 percentage of participants |
| Treatment Prevention for Secondary CV | Efficacy Endpoints | High adherence (8) | 62.7 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | Low adherence (0-5) | 5.5 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | Medium adherence (6-7) | 24.0 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | High adherence (8) | 70.6 percentage of participants |
Comparison: Statistical analysis title - Treatment adherence at 6 monthsp-value: <0.00595% CI: [1.06, 1.2]Chi-squared
Secondary
Efficacy Endpoints
Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | Low adherence (0-5) | 6.9 percentage of participants |
| Treatment Prevention for Secondary CV | Efficacy Endpoints | Medium adherence (6-7) | 29.8 percentage of participants |
| Treatment Prevention for Secondary CV | Efficacy Endpoints | High adherence (8) | 63.2 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | Low adherence (0-5) | 4.2 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | Medium adherence (6-7) | 21.7 percentage of participants |
| Cardiovascular Polypill | Efficacy Endpoints | High adherence (8) | 74.1 percentage of participants |
Comparison: Statistical analysis title - Treatment adherence at 24 monthsp-value: <0.00595% CI: [1.1, 1.25]Chi-squared
Secondary
Efficacy Endpoints
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 134.8 millimeters of mercury (mmHg) | Standard Deviation 18.1 |
| Cardiovascular Polypill | Efficacy Endpoints | 134.4 millimeters of mercury (mmHg) | Standard Deviation 17.7 |
Comparison: Statistical analysis title - SBP - 6 monthsp-value: <0.0595% CI: [-1.8, 1.2]ANCOVA
Secondary
Efficacy Endpoints
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 135.0 millimeters of mercury (mmHg) | Standard Deviation 18 |
| Cardiovascular Polypill | Efficacy Endpoints | 136.3 millimeters of mercury (mmHg) | Standard Deviation 17.5 |
Comparison: Statistical analysis title - SBP - 12 monthsp-value: <0.0595% CI: [-0.1, 3]ANCOVA
Secondary
Efficacy Endpoints
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 135.5 millimeters of mercury (mmHg) | Standard Deviation 17.1 |
| Cardiovascular Polypill | Efficacy Endpoints | 135.2 millimeters of mercury (mmHg) | Standard Deviation 16.9 |
Comparison: Statistical analysis title - SBP - 24 monthsp-value: <0.0595% CI: [-1.7, 1.4]ANCOVA
Secondary
Efficacy Endpoints
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 74.2 millimeters of mercury (mmHg) | Standard Deviation 9.9 |
| Cardiovascular Polypill | Efficacy Endpoints | 74.3 millimeters of mercury (mmHg) | Standard Deviation 10.2 |
Comparison: Statistical analysis title - DBP - 6 monthsp-value: <0.0595% CI: [-0.7, 1]ANCOVA
Secondary
Efficacy Endpoints
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 74.1 millimeters of mercury (mmHg) | Standard Deviation 9.8 |
| Cardiovascular Polypill | Efficacy Endpoints | 74.7 millimeters of mercury (mmHg) | Standard Deviation 9.9 |
Comparison: Statistical analysis title - DBP - 12 monthsp-value: <0.0595% CI: [-0.1, 1.6]ANCOVA
Secondary
Efficacy Endpoints
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 74.9 millimeters of mercury (mmHg) | Standard Deviation 9.7 |
| Cardiovascular Polypill | Efficacy Endpoints | 74.8 millimeters of mercury (mmHg) | Standard Deviation 10.1 |
Comparison: Statistical analysis title - DBP - 24 monthsp-value: <0.0595% CI: [-0.9, 1]ANCOVA
Secondary
Efficacy Endpoints
Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 66.3 mg/dL | Standard Deviation 25.4 |
| Cardiovascular Polypill | Efficacy Endpoints | 69.2 mg/dL | Standard Deviation 24.7 |
Comparison: Statistical analysis title - LDL cholesterol - 12 monthsp-value: <0.0595% CI: [-0.2, 4.4]ANCOVA
Secondary
Efficacy Endpoints
Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 67.2 mg/dL | Standard Deviation 25.4 |
| Cardiovascular Polypill | Efficacy Endpoints | 67.7 mg/dL | Standard Deviation 23.6 |
Comparison: Statistical analysis title - LDL cholesterol - 24 monthsp-value: <0.0595% CI: [-2.5, 2.4]ANCOVA
Secondary
Efficacy Endpoints
The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death (CV death); Acute Myocardial Infarction (MI) type 1; stroke. Measured in number of cases.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 144 number of events |
| Cardiovascular Polypill | Efficacy Endpoints | 101 number of events |
p-value: <0.02595% CI: [0.54, 0.9]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 71 number of events |
| Cardiovascular Polypill | Efficacy Endpoints | 48 number of events |
p-value: <0.02595% CI: [0.47, 0.97]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
Domain Convenience score of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 70.19 score on a scale | Standard Deviation 17.06 |
| Cardiovascular Polypill | Efficacy Endpoints | 77.30 score on a scale | Standard Deviation 15.95 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [5.55, 8.67]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain Global satisfaction score of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 67.76 score on a scale | Standard Deviation 17.87 |
| Cardiovascular Polypill | Efficacy Endpoints | 74.36 score on a scale | Standard Deviation 17.52 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [4.93, 8.27]t-test, 2 sided
Secondary
Efficacy Endpoints
The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 62 number of events |
| Cardiovascular Polypill | Efficacy Endpoints | 44 number of events |
p-value: <0.02595% CI: [0.48, 1.05]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 27 number of events |
| Cardiovascular Polypill | Efficacy Endpoints | 19 number of events |
p-value: <0.02595% CI: [0.39, 1.26]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 28 number of events |
| Cardiovascular Polypill | Efficacy Endpoints | 27 number of events |
p-value: <0.02595% CI: [0.57, 1.63]Regression, Cox
p-value: <0.05Log Rank
Secondary
Efficacy Endpoints
Domain effectiveness of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 69.17 score on a scale | Standard Deviation 17.57 |
| Cardiovascular Polypill | Efficacy Endpoints | 72.26 score on a scale | Standard Deviation 17.85 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [1.38, 4.79]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain Side effects score of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 66.71 score on a scale | Standard Deviation 23.38 |
| Cardiovascular Polypill | Efficacy Endpoints | 61.52 score on a scale | Standard Deviation 23.18 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [-12.73, 2.35]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain Convenience score of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 69.47 score on a scale | Standard Deviation 16.87 |
| Cardiovascular Polypill | Efficacy Endpoints | 76.56 score on a scale | Standard Deviation 14.78 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [5.57, 8.62]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain Global satisfaction score of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 67.71 score on a scale | Standard Deviation 18.53 |
| Cardiovascular Polypill | Efficacy Endpoints | 71.50 score on a scale | Standard Deviation 18.06 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [2.04, 5.55]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain effectiveness of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 68.79 score on a scale | Standard Deviation 17.65 |
| Cardiovascular Polypill | Efficacy Endpoints | 74.06 score on a scale | Standard Deviation 17.86 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [3.59, 6.94]t-test, 2 sided
Secondary
Efficacy Endpoints
Domain Side effects score of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Side effects score) the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Prevention for Secondary CV | Efficacy Endpoints | 64.20 score on a scale | Standard Deviation 23.14 |
| Cardiovascular Polypill | Efficacy Endpoints | 68.75 score on a scale | Standard Deviation 24.83 |
Comparison: Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).p-value: <0.0595% CI: [-4.35, 13.46]t-test, 2 sided
Secondary
Safety Endpoints
All-cause mortality.
Time frame: Up to 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Safety Endpoints | 117 number of events |
| Cardiovascular Polypill | Safety Endpoints | 115 number of events |
Comparison: Statistical analysis title - All-cause deathp-value: <0.0595% CI: [0.75, 1.25]Log Rank
Secondary
Safety Endpoints
The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.
Time frame: Up to 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Prevention for Secondary CV | Safety Endpoints | 46 number of events |
| Cardiovascular Polypill | Safety Endpoints | 67 number of events |
Comparison: Statistical analysis title - Non-cardiovascular deathp-value: <0.0595% CI: [0.97, 2.07]Log Rank