PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril

Study Overview
=================
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.

Official Title
-----------------
Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/PerindopRil In Patients With Previous Myocardial Infraction With Arterial Hypertension in the Daily Clinical practicE

Conditions
-----------------
Coronary Artery Disease, Myocardial Infarction, Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: in daily everyday routine practice


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: in daily everyday routine practice|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antihypertensive effectiveness (SBP and DBP reduction) of bisoprolol/perindopril SPC in CAD patients with previous MI and HTN at week 12 of treatment | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean systolic and diastolic BP levels at week 4 | 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 | 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 | 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 | 
| Proportion of patients receiving LLT who achieved target levels of LDL | Proportion of patients receiving LLT who achieved target levels of LDL C at week 12 of treatment. | 3 months | 
| SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4. | 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 | 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 | 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 | Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline | 1 month | 
| mean heart rate (HR) at week 12 | 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 | 
| Changes in the quality of life assessed by Health Questionnaire EuroQol (EQ-5D-5L) at week 4 | Changes in the quality of life assessed by Health Questionnaire EuroQol (abbreviated as EQ-5D-5L, scale is numbered from 0 to 100; 100 means the best health; 0 means the worst health) at week 4 of treatment compared with baseline | 1 month | 
| Changes in the quality of life assessed by Health Questionnaire EuroQol (EQ-5D-5L) at week 12 | Changes in the quality of life assessed by Health Questionnaire EuroQol (abbreviated as EQ-5D-5L, scale is numbered from 0 to 100; 100 means the best health; 0 means the worst health) at week 12 of treatment compared with baseline | 3 month |