PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril

NCT04656847 | Completed Results

• 1 other identifier: IC4-05150-065-RUS
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

This non-interventional, ambispective study was aimed at evaluating the effectiveness, safety, and tolerability of bisoprolol and perindopril SPC in previous myocardial infarction patients with HTN and CAD treated with the drug for 12 weeks in the daily clinical practice. SPC will be used according to the approved instruction for medical use of the medicine. This is a multi-centre, observational, incomparative, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with HTN and previous MI initiated with bisoprolol/perindopril SPC in real life settings.

Conditions

Coronary Artery Disease; Myocardial Infarction; Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Antihypertensive Effectiveness (SBP and DBP) of Bisoprolol/Perindopril SPC in CAD Patients With Previous MI and HTN at Week 12 of Treatment Compared With Baseline

  Change in the mean systolic and diastolic BP levels at week 12 of treatment with SPC compared with baseline among patients included in the study.

  3 months

Secondary Outcomes (14)

• Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline.

  1 month

• Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.

  1 month

• Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline

  3 months

• Proportion of Patients Who Were Taking Lipid Lowering Therapy

  3 months

• SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline

  1 month

Interventions

in daily everyday routine practice DRUG

patients with HTN and CAD treated with the the single pill combination bisoprolol/perindopril for 12 weeks in the daily clinical practice Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion criteria for entering the study allows mitigating a potential risk of deliberative medicine administration within the observational program.

Also known as: Baseline data will be collected retrospectively from medical records of stable CAD patients with HTN and a history of MI, including disease history of the patient.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CAD patients with previous MI and HTN

You may qualify if:

• HTN (including resistant\* hypertension)
• Signed informed consent to participate in the study.
• Bisoprolol/ perindopril SPC prescription\*\* within 3 month period before Index date

You may not qualify if:

• Hypersensitivity to bisoprolol, perindopril, excipients of the medicine, or other ACE inhibitors.
• Any contraindication for bisoprolol/perindopril's SPC according to the instruction for medical use
• CAD, angina pectoris of functional class IV according to the CCS classification (Appendix 1).
• Chronic heart failure of class III-IV according to the New York Heart Association (NYHA) functional classification of heart failure (Appendix 3).
• Hypertrophic obstructive cardiomyopathy.
• Office BP ≥ 180/110 mm Hg on treatment
• Type 1 diabetes mellitus and decompensated type 2 diabetes mellitus.
• Bradycardia with a heart rate of less than 60 beats per minute.
• Atrioventricular block (II-III degree), sinoatrial block, or sick sinus syndrome.
• Severe bronchial asthma or severe chronic obstructive pulmonary disease.
• Arterial hypotension (BP less than 100/70 mm Hg).
• Pregnancy, breastfeeding.
• Secondary hypertension.
• Severe decompensated diseases of organs and systems requiring continuous treatment.
• Current participation in another clinical trial and within 30 days prior to signing informed consent.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Peoples' Friendship University of Russia

Moscow, Russia

Location

Related Publications (1)

• Kobalava Z, Kvasnikov B, Burtsev Y; PRIDE study investigators. Effectiveness and Tolerability of Bisoprolol/Perindopril Single-Pill Combination in Patients with Arterial Hypertension and a History of Myocardial Infarction: The PRIDE Observational Study. Adv Ther. 2023 Jun;40(6):2725-2740. doi: 10.1007/s12325-023-02462-9. Epub 2023 Apr 8.

  PMID: 37029871 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Hypertension

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Medical manager - Yuriy Burtsev
• Organization: Sevier

Yuriy.Burtsev@servier.com

8-495-93707-00

Study Officials

• Zhanna Kobalava, Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: March 1, 2021
• Primary Completion: October 5, 2021
• Study Completion: October 18, 2021
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)