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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.
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:
Secondary endpoints:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the patients with HT and concomitant stable CAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bisoprolol/perindopril FDC | Drug | the first and only single-pill combination of beta-blocker and ACE inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sergei Boytsov | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSBI NMIC of Cardiology of the Ministry of Health of Russia | Moscow | 121552 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33991323 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | the Patients With HT and Concomitant Stable CAD | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inclusion |
| ||||||||||||||||
| 1 Month After Inclusion |
| ||||||||||||||||
| 3 Month After Inclusion |
|
1909 patients were included however 17 were excluded from the population analysed due to violation of inclusion creteria. Therefore full analysis set is 1892.
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| ID | Title | Description |
|---|---|---|
| BG000 | the Patients With HT and Concomitant Stable CAD | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | patients with arterial hypertension and stable coronary heart disease |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mm Hg | 3 months |
|
|
3 month
Were registered 9 AEs in 4 patients, of which 3 patients had adverse drug reactions resulting in the withdrawal from treatment. 1 patient started to take the study drug periodically and not daily, which did not comply with the instructions for the medical use of the drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | the Patients With HT and Concomitant Stable CAD | Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-traumatic vertebral compression fracture that required hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry cough and tingling throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrdical manager - Yuriy Burtsev | Sevier | 8-495-93707-00 | 1389 | Yuriy.Burtsev@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Oct 22, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2018 | Oct 22, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| 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 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | - in 11 participants no gender indicated | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | number of angina attacks per week | 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 | Posted | Mean | Standard Deviation | mm Hg | 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 | Posted | Mean | Standard Deviation | units on a scale - mm | 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) | Posted | Count of Participants | Participants | 3 month |
|
|
|
| 1 |
| 1,909 |
| 7 |
| 1,909 |
| 2 |
| 1,909 |
|
| death of unknown caus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypotension with dizziness | Cardiac disorders | Non-systematic Assessment |
|
| bradycardia | Product Issues | Non-systematic Assessment |
|
| bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| syncope | Cardiac disorders | Non-systematic Assessment |
|
| A special situation: use of the drug not daily, but as needed | Cardiac disorders | Non-systematic Assessment |
|
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| D006331 |
| Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |