An observational study in Coronary Artery Disease, Myocardial Infarction and Arterial Hypertension, sponsored by Servier Russia. Completed at 1 site in Russia. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Servier Russia · Observational
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.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 504 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Servier Russia is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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CAD patients with previous MI and HTN
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
HTN (including resistant* hypertension)
Exclusion Criteria:
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.
Also known as: 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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | CAD Patients With Previous MI and HTN |
|---|---|
| Started | 504 |
| Lipid lowering therapy | 463 |
| Completed | 504 |
| Not completed | 0 |
| Milestone | CAD Patients With Previous MI and HTN |
|---|---|
| Started | 504 |
| 3 month after inclusion | 504 |
| Lipid lowering therapy | 463 |
| Completed | 481 |
| Not completed | 23 |
| Withdrew: Lack of data on myocardial infarction and/or data by visits | 23 |
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.
| mm Hg | CAD Patients With Previous MI and HTN |
|---|---|
| SBP | -24.92 ± 16.43 |
| DBP | -12.21 ± 11.03 |
Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline.
| mm Hg | CAD Patients With Previous MI and HTN |
|---|---|
| Systolic BP | -17.32 ± 13.97 |
| Dyastolic BP | -8.39 ± 8.79 |
Change in number of angina attacks per week at week 4 of treatment compared with baseline.
| angina attacks per week | CAD Patients With Previous MI and HTN |
|---|---|
| Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline. | 2.76 ± 2.26 |
Change in number of angina attacks per week at week 12 of treatment compared with baseline.
| angina attacks per week | CAD Patients With Previous MI and HTN |
|---|---|
| Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline | 0.95 ± 0.94 |
Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment
| Number of Participants Who Were Taking L | CAD Patients With Previous MI and HTN |
|---|---|
| Proportion of Patients Who Were Taking Lipid Lowering Therapy | 397 |
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4.
| Participants | CAD Patients With Previous MI and HTN |
|---|---|
| SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline | 330 |
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 12
| Participants | CAD Patients With Previous MI and HTN |
|---|---|
| SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline | 417 |
Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 4 of treatment
| 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 |
Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 12 of treatment.
| 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 |
Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 4 of treatment
| 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 |
Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 12 of treatment
| 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 |
Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline
| beats per minute | CAD Patients With Previous MI and HTN |
|---|---|
| Mean Heart Rate (HR) at Week 4 Compared With Baseline. | -10.87 ± 10.36 |
Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline
| beats per minute | CAD Patients With Previous MI and HTN |
|---|---|
| Mean Heart Rate (HR) at Week 12 Compared With Baseline. | -14.44 ± 11.69 |
Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 4 of treatment.
| Participants | CAD Patients With Previous MI and HTN |
|---|---|
| Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4 | 82 |
Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 12 of treatment.
| Participants | CAD Patients With Previous MI and HTN |
|---|---|
| Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12 | 150 |
Collected over 3 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAD Patients With Previous MI and HTN | 0/504 (0%) | 0/504 (0%) | 0/504 (0%) |
The study enrolled 504 patients. Of them, 481 (95.44%) were included in the population for analysis. Withdrawal of 23 patients occurred due to lack of data on myocardial infarction and/or data by visits of the study.
| Age, Continuous(years) | CAD Patients With Previous MI and HTN |
|---|---|
| Mean | 61.38 ± 8.87 |
| Sex: Female, Male(Participants) | CAD Patients With Previous MI and HTN |
|---|---|
| Female | 154 |
| Male | 327 |
| Race and Ethnicity Not Collected(Participants) | CAD Patients With Previous MI and HTN |
|---|
| Region of Enrollment(participants) | CAD Patients With Previous MI and HTN |
|---|---|
| Russia | 481 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Mar 2021 to primary completion in Oct 2021, 7 months.
Results were first posted in Nov 2024, 3 years after primary completion.
Of 131 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 42. This study's 7 months is below that.
Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Servier Russia