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

Arterial Hypertension Clinical Trial

— STYLE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730116
• Other study ID #: IC4-05150-056-RUS
• Status: Completed
• Start date: November 14, 2018
• Est. completion date: October 24, 2019

Study information

• Verified date: November 2020
• Source: Servier Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1909
• Est. completion date: October 24, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• CHD - Coronary Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertension
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	FSBI NMIC of Cardiology of the Ministry of Health of Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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