Arterial HypertensionSTYLENCT03730116

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

An observational study of Arterial Hypertension and CHD - Coronary Heart Disease, run by Servier Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Arterial Hypertension, CHD - Coronary Heart Disease
What is being tested?: bisoprolol/perindopril FDC
Type of treatment: Pill or oral medicine
How many people: 1,909 participants
Where: 1 siteRussia
Study dates: 14 Nov 2018to 24 Oct 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

FSBI NMIC of Cardiology of the Ministry of Health of Russia
Moscow, 121552

Other trials in Russia

About this study

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 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.

Read the 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

Conditions: Arterial Hypertension, CHD - Coronary Heart Disease
Being tested: bisoprolol/perindopril FDC
Medical subject headings: Hypertension, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bisoprolol/perindopril FDCDrug
the first and only single-pill combination of beta-blocker and ACE inhibitor

Study groups in NCT03730116
Study group	Role	What they receive
the patients with HT and concomitant stable CAD		Not described Receives: Drug: bisoprolol/perindopril FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 3 month
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)
Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 201824 Oct 2019

First posted5 Nov 2018
Study start14 Nov 2018
Primary completion24 Oct 2019
Study completion24 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arterial HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 1,909 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03730116
Sponsor's protocol ID: IC4-05150-056-RUS
Acronym: STYLE
Status last verified: Nov 2020
First submitted: 22 Oct 2018
Last updated: 13 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 33991323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03730116
Acronym / sponsor ID: STYLE / IC4-05150-056-RUS
Conditions: Arterial Hypertension, CHD - Coronary Heart Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,909 participants (actual)
Lead sponsor: Servier RussiaIndustry (pharma, biotech, devices)
Study start: 14 Nov 2018 (actual)
Primary completion: 24 Oct 2019 (actual)
Study completion: 24 Oct 2019 (actual)
First posted: 5 Nov 2018 (actual)
Results: Posted 23 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice.

Detailed description

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 design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
the patients with HT and concomitant stable CAD	–	Drug: bisoprolol/perindopril FDC

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bisoprolol/perindopril FDCthe first and only single-pill combination of beta-blocker and ACE inhibitor	Drug	the patients with HT and concomitant stable CAD

Primary outcome

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
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
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
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

2 secondary outcomes

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
Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice
Time frame: 3 month

Results and safety

Results posted to the registry on 23 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
the Patients With HT and Concomitant Stable CAD	1,909	1,909

Primary outcome: The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline

Time frame: 3 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Mean of SBP Changes n = 1892
Value	31.5 (14.2)

Primary outcome: 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. Count of participants. Unit: Participants

Measure	the Patients With HT and Concomitant Stable CAD n = 1892
Value	1640

Primary outcome: Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks

Time frame: 3 month. Mean (Standard Deviation). Unit: number of angina attacks per week

Measure	the Patients With HT and Concomitant Stable CAD n = 1892
Value	-3.2 (8.2)

Primary outcome: Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position

Time frame: 3 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Mean Office DBP Changes Between v3 vs Baseline n = 1892
Value	15.9 (9.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
the Patients With HT and Concomitant Stable CAD	7 of 1,909 (0.4%)	2 of 1,909 (0.1%)	1 of 1,909

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33991323Boytsov 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.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sergei Boytsov study chair

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Hypertension and CHD - Coronary Heart Disease, run by Servier Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730116, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.