Arterial Hypertension, Coronary Artery Disease, Myocardial Infarction
Conditions
Brief summary
This non-interventional, ambispective study was aimed at evaluating the effectiveness, safety, and tolerability of bisoprolol and perindopril SPC in previous myocardial infarction patients with HTN and CAD treated with the drug for 12 weeks in the daily clinical practice. SPC will be used according to the approved instruction for medical use of the medicine. This is a multi-centre, observational, incomparative, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with HTN and previous MI initiated with bisoprolol/perindopril SPC in real life settings.
Detailed description
This is a multi-centre, observational, incomparative, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with HTN and previous MI initiated with bisoprolol/perindopril SPC in real life settings. Baseline data will be collected retrospectively from medical records of stable CAD patients with HTN and a history of MI, including disease history of the patient. To be included in the study for further prospective observation a patient should have been administered bisoprolol/ perindopril SPC within first three months before the Index Date. (Fig.1). Therefore, criteria for non-inclusion or inclusion of the patient in the study are to be retrospectively evaluated by the investigator using recorded clinical data available from medical records. Once a physician makes decision to include a patient in the study and, in particular, on the prospective observation for 3 months, a visit to the clinic for obtaining signed patient's consent to participate in the study should be appointed and made within 1 month from the Index Date. Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion criteria for entering the study allows mitigating a potential risk of deliberative medicine administration within the observational program. Such studies are carried out in case of observational programs when the studied drug is administered in line with indications according to the instruction for its medical use. Several multicenter, non-interventional, open, incomparable studies have been performed with bisoprolol/perindopril SPC in patients with HTN and coronary heart disease. A total of 70 general practitioners and cardiologists from primary care facilities will participate in the program. Each doctor will include about 7-8 patients. In total, it is planned to include at least 500 patients.
Interventions
patients with HTN and CAD treated with the the single pill combination bisoprolol/perindopril for 12 weeks in the daily clinical practice Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion criteria for entering the study allows mitigating a potential risk of deliberative medicine administration within the observational program.
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with stable angina pectoris of class I-III according to the Canadian Cardiovascular Society (CCS) classification and a history of myocardial infarction no earlier (not less) than 3 months before inclusion in the study. HTN (including resistant\* hypertension) * Signed informed consent to participate in the study. * Bisoprolol/ perindopril SPC prescription\*\* within 3 month period before Index date
Exclusion criteria
* Hypersensitivity to bisoprolol, perindopril, excipients of the medicine, or other ACE inhibitors. * Any contraindication for bisoprolol/perindopril's SPC according to the instruction for medical use * CAD, angina pectoris of functional class IV according to the CCS classification (Appendix 1). * Chronic heart failure of class III-IV according to the New York Heart Association (NYHA) functional classification of heart failure (Appendix 3). * Cerebrovascular diseases (ischemic, haemorrhagic stroke, or transient ischemic attack) within the past 6 months prior to inclusion in the study. * A history of revascularization procedure within 3 months prior to inclusion in the study. * Hypertrophic obstructive cardiomyopathy. * Office BP ≥ 180/110 mm Hg on treatment * Type 1 diabetes mellitus and decompensated type 2 diabetes mellitus. * Bradycardia with a heart rate of less than 60 beats per minute. * Atrioventricular block (II-III degree), sinoatrial block, or sick sinus syndrome. * Severe bronchial asthma or severe chronic obstructive pulmonary disease. * Arterial hypotension (BP less than 100/70 mm Hg). * Pregnancy, breastfeeding. * Secondary hypertension. * Severe decompensated diseases of organs and systems requiring continuous treatment. * Current participation in another clinical trial and within 30 days prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antihypertensive Effectiveness (SBP and DBP) of Bisoprolol/Perindopril SPC in CAD Patients With Previous MI and HTN at Week 12 of Treatment Compared With Baseline | 3 months | Change in the mean systolic and diastolic BP levels at week 12 of treatment with SPC compared with baseline among patients included in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline. | 1 month | Change in number of angina attacks per week at week 4 of treatment compared with baseline. |
| Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline | 3 months | Change in number of angina attacks per week at week 12 of treatment compared with baseline. |
| Proportion of Patients Who Were Taking Lipid Lowering Therapy | 3 months | Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment |
| SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline | 1 month | Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4. |
| SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline | 3 months | Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 12 |
| Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline | 1 month | Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 4 of treatment |
| Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. | 1 month | Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline. |
| Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment | 1 month | Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 4 of treatment |
| Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment | 3 months | Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 12 of treatment |
| Mean Heart Rate (HR) at Week 4 Compared With Baseline. | 1 month | Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline |
| Mean Heart Rate (HR) at Week 12 Compared With Baseline. | 3 months | Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline |
| Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4 | 1 month | Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 4 of treatment. |
| Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12 | 3 months | Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 12 of treatment. |
| Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment | 3 months | Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 12 of treatment. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAD Patients With Previous MI and HTN Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor | 481 |
| Total | 481 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3 Month After Inclusion | lack of data on myocardial infarction and/or data by visits | 23 |
Baseline characteristics
| Characteristic | CAD Patients With Previous MI and HTN | — |
|---|---|---|
| Age, Continuous | 61.38 years STANDARD_DEVIATION 8.87 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 481 participants | — |
| Sex: Female, Male Female | 154 Participants | — |
| Sex: Female, Male Male | 327 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 504 |
| other Total, other adverse events | 0 / 504 |
| serious Total, serious adverse events | 0 / 504 |
Outcome results
Primary
Antihypertensive Effectiveness (SBP and DBP) of Bisoprolol/Perindopril SPC in CAD Patients With Previous MI and HTN at Week 12 of Treatment Compared With Baseline
Change in the mean systolic and diastolic BP levels at week 12 of treatment with SPC compared with baseline among patients included in the study.
Time frame: 3 months
Population: Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAD Patients With Previous MI and HTN | Antihypertensive Effectiveness (SBP and DBP) of Bisoprolol/Perindopril SPC in CAD Patients With Previous MI and HTN at Week 12 of Treatment Compared With Baseline | SBP | -24.92 mm Hg | Standard Deviation 16.43 |
| CAD Patients With Previous MI and HTN | Antihypertensive Effectiveness (SBP and DBP) of Bisoprolol/Perindopril SPC in CAD Patients With Previous MI and HTN at Week 12 of Treatment Compared With Baseline | DBP | -12.21 mm Hg | Standard Deviation 11.03 |
Secondary
Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline.
Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAD Patients With Previous MI and HTN | Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. | Systolic BP | -17.32 mm Hg | Standard Deviation 13.97 |
| CAD Patients With Previous MI and HTN | Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. | Dyastolic BP | -8.39 mm Hg | Standard Deviation 8.79 |
Secondary
Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline
Change in number of angina attacks per week at week 12 of treatment compared with baseline.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD Patients With Previous MI and HTN | Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline | 0.95 angina attacks per week | Standard Deviation 0.94 |
Secondary
Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.
Change in number of angina attacks per week at week 4 of treatment compared with baseline.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD Patients With Previous MI and HTN | Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline. | 2.76 angina attacks per week | Standard Deviation 2.26 |
Secondary
Mean Heart Rate (HR) at Week 12 Compared With Baseline.
Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD Patients With Previous MI and HTN | Mean Heart Rate (HR) at Week 12 Compared With Baseline. | -14.44 beats per minute | Standard Deviation 11.69 |
Secondary
Mean Heart Rate (HR) at Week 4 Compared With Baseline.
Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD Patients With Previous MI and HTN | Mean Heart Rate (HR) at Week 4 Compared With Baseline. | -10.87 beats per minute | Standard Deviation 10.36 |
Secondary
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment
Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 12 of treatment
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment | 162 Participants |
Secondary
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment
Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 4 of treatment
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment | 109 Participants |
Secondary
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12
Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 12 of treatment.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12 | 150 Participants |
Secondary
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4
Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 4 of treatment.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4 | 82 Participants |
Secondary
Proportion of Patients Who Were Taking Lipid Lowering Therapy
Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Proportion of Patients Who Were Taking Lipid Lowering Therapy | 397 Number of Participants Who Were Taking L |
Secondary
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 12
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline | 417 Participants |
Secondary
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline | 330 Participants |
Secondary
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment
Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 12 of treatment.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment | 143 Participants |
Secondary
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline
Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 4 of treatment
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAD Patients With Previous MI and HTN | Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline | 86 Participants |