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

December 23, 2020 updated by: Servier Russia

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1909

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121552
        • FSBI NMIC of Cardiology of the Ministry of Health of Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the patients with HT and concomitant stable CAD
Drug: bisoprolol/perindopril FDC
the first and only single-pill combination of beta-blocker and ACE inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline
Time Frame: 3 months
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
Time Frame: 3 month
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
Time Frame: 3 month
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
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC
3 month
Good and Moderate 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)
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Russia

Investigators

  • Study Chair: Sergei Boytsov

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2018

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

October 24, 2019

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC4-05150-056-RUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The sponsor reserves the exclusive right to all materials, information, unpublished documentation, results and information obtained during the research. The Sponsor reserves the right to send research data to the health authorities (individual registration cards, analysis results, reports).

No unpublished documentation or information transmitted to researchers can be transferred to unauthorized persons without the prior written consent of Sponsor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arterial Hypertension

Clinical Trials on bisoprolol/perindopril FDC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe