Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril

Study Overview
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Brief Summary
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Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice. Type of the program: multicenter, observational, uncontrolled, open program. The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities.Each doctor includes four patients. It is planned to include not less than 1920 patients in total.

Detailed Description
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Multicenter observational open program. Assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and stable CAD in daily clinical practice (STYLE) Study objectives and purposes: Primary endpoints: efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina Secondary endpoints: impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice adherence to bisoprolol/perindopril FDC therapy in patients with HT and stable CAD in everyday practice The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities. Each doctor includes four patients. It is planned to include not less than 1920 patients in total. Milestones of the program: FSI - November, 2018 LSLV- January, 2019 Database Lock - February, 2019 Statistic Report- May, 2019 Clinical Study Report- January, 2020

Official Title
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Multicenter Observational Open Program. Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril in Patients With Arterial Hypertension and Stable CAD in Daily Clinical Practice (STYLE)

Conditions
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Arterial Hypertension, CHD - Coronary Heart Disease

Intervention / Treatment
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* Drug: bisoprolol/perindopril FDC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable CAD, defined as stable angina pectoris of class 1-3 by CCS (Canadian Cardiovascular Society) classification; Previously or newly diagnosed essential hypertension Age 18 to 79 years old; Informed consent of the patient for participation in the program; Decision of the doctor to prescribe bisoprolol/perindopril FDC before the inclusion in the program in accordance to the instruction for use. Exclusion Criteria: Stable angina pectoris, class 4; History of myocardial infarction or cerebrovascular event within the past 3 months; Unstable angina within the past 6 months; Chronic heart failure classes 3-4 (NYHA); Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus; Any serious decompensated concomitant diseases requiring the regular medical therapy; Inability to understand the essence of the program and follow the recommendations; Contraindications to beta-blockers or ACE inhibitors using; Participation of the patient in other trials in the present time or within 30 days before the start of observational program.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the patients with HT and concomitant stable CAD<br> | Drug: bisoprolol/perindopril FDC<br>* the first and only single-pill combination of beta-blocker and ACE inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | Changes in the mean office systolic BP levels (in mm Hg) in the sitting position | 3 months | 
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP < 140 mm Hg and DBP < 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC | 3 month | 
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC | 3 month | 
| Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC | 3 month | 
| Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | Percentage of the patients with definite answer on question from questionnaire regarding adherence; (Compliance evaluation test - 6 questions tes; Answer No to all questions: good compliance; Answer Yes to 1-2 questions: minor compliance; Answer Yes to 3 or more questions: noncompliance) | 3 month |