NCT03730116: STYLE

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

Completed Results posted Last updated 13 January 2021

What this trial tests

trial testing bisoprolol/perindopril FDC in Arterial Hypertension in 1,909 participants. Completed in 24 October 2019.

Timeline

14 November 2018

Primary endpoint
24 October 2019

24 October 2019

Quick facts

Lead sponsor	Servier Russia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,909
Start date	14 November 2018
Primary completion	24 October 2019
Estimated completion	24 October 2019
Sites	1 location across Russia

Drugs / interventions tested

• bisoprolol/perindopril FDC — full drug profile →

Conditions studied

• Arterial Hypertension — all drugs for Arterial Hypertension →
• CHD - Coronary Heart Disease — all drugs for CHD - Coronary Heart Disease →

Sponsor

Servier Russia — full company profile →

Who can join

Adults 18 to 79, any sex, with Arterial Hypertension or CHD - Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Changes in the mean office systolic BP levels (in mm Hg) in the sitting position

Group	Value	95% CI
Mean of SBP Changes	31.5	± 14.2

Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels Primary · 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

Group	Value	95% CI
the Patients With HT and Concomitant Stable CAD	1640

Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks Primary · 3 month

Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC

Group	Value	95% CI
the Patients With HT and Concomitant Stable CAD	-3.2	± 8.2

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

Group	Value	95% CI
Mean Office DBP Changes Between v3 vs Baseline	15.9	± 9.5

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

Group	Value	95% CI
the Patients With HT and Concomitant Stable CAD	35.1	± 18.5

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

Group	Value	95% CI
the Patients With HT and Concomitant Stable CAD	1827

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

the Patients With HT and Concomitant Stable CAD

Serious: 7/1909 (0%)

Deaths: 1/1909

Serious adverse events (6 terms)

Reaction	System	the Patients With HT and C…
Hypotension with dizziness	Cardiac disorders	—
Non-traumatic vertebral compression fracture that required hospitalization	Musculoskeletal and connective tissue disorders	—
death of unknown caus	Musculoskeletal and connective tissue disorders	—
bradycardia	Product Issues	—
bradycardia	Cardiac disorders	—
syncope	Cardiac disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	the Patients With HT and C…
Dry cough and tingling throat	Respiratory, thoracic and mediastinal disorders	—
A special situation: use of the drug not daily, but as needed	Cardiac disorders	—

Most-reported serious reactions: Hypotension with dizziness, Non-traumatic vertebral compression fracture that required hospitalization, death of unknown caus, bradycardia, bradycardia, syncope.

Data from ClinicalTrials.gov NCT03730116 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Boytsov SA, Burtsev YP, Khomitskaya YV, Karpov YA, et al · · 2021 · cited 5× · PMID 33991323 · DOI 10.1007/s12325-021-01754-2