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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in daily everyday routine practice | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline. |
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Inclusion Criteria:
HTN (including resistant* hypertension)
Exclusion Criteria:
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CAD patients with previous MI and HTN
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| Name | Affiliation | Role |
|---|---|---|
| Zhanna Kobalava, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peoples' Friendship University of Russia | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37029871 | Derived | Kobalava Z, Kvasnikov B, Burtsev Y; PRIDE study investigators. Effectiveness and Tolerability of Bisoprolol/Perindopril Single-Pill Combination in Patients with Arterial Hypertension and a History of Myocardial Infarction: The PRIDE Observational Study. Adv Ther. 2023 Jun;40(6):2725-2740. doi: 10.1007/s12325-023-02462-9. Epub 2023 Apr 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CAD Patients With Previous MI and HTN | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 Month After Inclusion |
| ||||||||||||||||
| 3 Month After Inclusion |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAD Patients With Previous MI and HTN | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | mm Hg | 3 months |
|
3 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAD Patients With Previous MI and HTN | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical manager - Yuriy Burtsev | Sevier | 8-495-93707-00 | Yuriy.Burtsev@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2020 | Feb 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Feb 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Change in number of angina attacks per week at week 4 of treatment compared with baseline. |
| 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. | 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 | 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. | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 3 months |
| COMPLETED | The study enrolled 504 patients. Of them, 481 (95.44%) were included in the population for full analysis set (FAS ). |
|
| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | mm Hg | 1 month |
|
|
|
| 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. | Posted | Mean | Standard Deviation | angina attacks per week | 1 month |
|
|
|
| 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. | Posted | Mean | Standard Deviation | angina attacks per week | 3 months |
|
|
|
| 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 | Posted | Number | Number of Participants Who Were Taking L | 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1 month |
|
|
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| 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | beats per minute | 1 month |
|
|
|
| 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 | Posted | Mean | Standard Deviation | beats per minute | 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 months |
|
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| 0 |
| 504 |
| 0 |
| 504 |
| 0 |
| 504 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |