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

NCT03730116 | Completed Results

• 1 other identifier: IC4-05150-056-RUS
• Study Type: observational
• Target: 1,909
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension; CHD - Coronary Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS

  3 month

• Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice

  3 month

Study Arms (1)

the patients with HT and concomitant stable CAD

Drug: bisoprolol/perindopril FDC

Interventions

bisoprolol/perindopril FDC DRUG

the first and only single-pill combination of beta-blocker and ACE inhibitor

the patients with HT and concomitant stable CAD

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

FSBI NMIC of Cardiology of the Ministry of Health of Russia

Moscow, 121552, Russia

Location

Related Publications (1)

• 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.

  PMID: 33991323 DERIVED

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Mrdical manager - Yuriy Burtsev
• Organization: Sevier

Yuriy.Burtsev@servier.com

8-495-93707-00

Study Officials

• Sergei Boytsov

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 5, 2018
• Study Start: November 14, 2018
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: January 13, 2021
• Results First Posted: December 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)