Clinical trial NCT03730116: Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
CHD - Coronary Heart Disease
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2018-11-05
Enrollment: 1909
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned to include into the program the patients with HT and concomitant stable CAD. It is planned to include not less than 1920 patients in total.

The patient is included in the program, if the doctor decides to prescribe FDC with beta-blocker bisoprolol and ACE inhibitor perindopril in accordance to the instruction for use.

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline
timeFrame: 3 months
measure: Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels
timeFrame: 3 month
measure: Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks
timeFrame: 3 month
measure: Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position
timeFrame: 3 months
Secondary outcomes:
measure: Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS
timeFrame: 3 month
measure: Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice
timeFrame: 3 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: FSBI NMIC of Cardiology of the Ministry of Health of Russia
Study officials:
name: Sergei Boytsov
role: STUDY_CHAIR
References:
citation: Boytsov SA, Burtsev YP, Khomitskaya YV, Karpov YA; STYLE study investigators. Effectiveness and Tolerability of the Single-Pill Combination of Bisoprolol and Perindopril in Patients with Arterial Hypertension and Stable Coronary Artery Disease in Daily Clinical Practice: The STYLE Study. Adv Ther. 2021 Jun;38(6):3299-3313. doi: 10.1007/s12325-021-01754-2. Epub 2021 May 15.