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

Servier

Status: Completed

Conditions: CHD - Coronary Heart Disease; Arterial Hypertension

Treatments: Drug: bisoprolol/perindopril FDC

Study type: Observational

Funder types: Industry

Identifiers

NCT03730116

IC4-05150-056-RUS

Details and patient eligibility

About

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 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

Enrollment: 1,909 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,909 participants in 1 patient group

the patients with HT and concomitant stable CAD

Treatment:

Drug: bisoprolol/perindopril FDC