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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730116
Recruitment Status : Completed
First Posted : November 5, 2018
Results First Posted : December 23, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Servier Russia

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.


Condition or disease Intervention/treatment
Arterial Hypertension CHD - Coronary Heart Disease Drug: bisoprolol/perindopril FDC

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

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Study Type : Observational
Actual Enrollment : 1909 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : November 14, 2018
Actual Primary Completion Date : October 24, 2019
Actual Study Completion Date : October 24, 2019


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




Primary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730116


Locations
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Russian Federation
FSBI NMIC of Cardiology of the Ministry of Health of Russia
Moscow, Russian Federation, 121552
Sponsors and Collaborators
Servier Russia
Investigators
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Study Chair: Sergei Boytsov
  Study Documents (Full-Text)

Documents provided by Servier Russia:
Informed Consent Form  [PDF] August 8, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Servier Russia
ClinicalTrials.gov Identifier: NCT03730116    
Other Study ID Numbers: IC4-05150-056-RUS
First Posted: November 5, 2018    Key Record Dates
Results First Posted: December 23, 2020
Last Update Posted: January 13, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Bisoprolol
Perindopril
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors