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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 30, 2020

Detailed Description

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

Interventions

  • Drug: bisoprolol/perindopril FDC
    • the first and only single-pill combination of beta-blocker and ACE inhibitor

Arms, Groups and Cohorts

  • the patients with HT and concomitant stable CAD

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP: % of patients achieving target levels
    • Time Frame: 3 month
    • Average decrease of systolic and diastolic BP (in mm Hg) to calculate percentage of the patients achieved the target levels of clinical BP among included patients ( SBP < 140 mm Hg and DBP < 90 mm Hg);
  • Efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice: # of angina attacks
    • Time Frame: 3 month
    • Average decrease of the number of angina attacks

Secondary Measures

  • Impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice: VAS
    • Time Frame: 3 month
    • • Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 and maximum score 10)
  • Adherence to bisoprolol/perindopril FDC therapy in patients with HT and stable CAD in everyday practice
    • Time Frame: 3 month
    • • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Servier Russia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Sergei Boytsov, proff, +7 (495) 415-01-44, prof.boytsov@gmail.com

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