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

NCT ID: NCT04656847

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 504 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-10-18

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.

Detailed Description

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.

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. To be included in the study for further prospective observation a patient should have been administered bisoprolol/ perindopril SPC within first three months before the Index Date. (Fig.1). Therefore, criteria for non-inclusion or inclusion of the patient in the study are to be retrospectively evaluated by the investigator using recorded clinical data available from medical records. Once a physician makes decision to include a patient in the study and, in particular, on the prospective observation for 3 months, a visit to the clinic for obtaining signed patient's consent to participate in the study should be appointed and made within 1 month from the Index Date.

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. Such studies are carried out in case of observational programs when the studied drug is administered in line with indications according to the instruction for its medical use.

Several multicenter, non-interventional, open, incomparable studies have been performed with bisoprolol/perindopril SPC in patients with HTN and coronary heart disease. A total of 70 general practitioners and cardiologists from primary care facilities will participate in the program. Each doctor will include about 7-8 patients. In total, it is planned to include at least 500 patients.

Conditions

Coronary Artery Disease; Myocardial Infarction; Arterial Hypertension

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

in daily everyday routine practice

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.

Intervention Type: DRUG

Other Intervention Names

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

Inclusion Criteria

• Patients with stable angina pectoris of class I-III according to the Canadian Cardiovascular Society (CCS) classification and a history of myocardial infarction no earlier (not less) than 3 months before inclusion in the study.

HTN (including resistant* hypertension)

• Signed informed consent to participate in the study.
• Bisoprolol/ perindopril SPC prescription** within 3 month period before Index date

Exclusion Criteria

• 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).
• Cerebrovascular diseases (ischemic, haemorrhagic stroke, or transient ischemic attack) within the past 6 months prior to inclusion in the study.
• A history of revascularization procedure within 3 months prior to inclusion in the study.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Servier Russia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhanna Kobalava, Professor

Role: PRINCIPAL_INVESTIGATOR

Locations

Peoples' Friendship University of Russia

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 37029871 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IC4-05150-065-RUS

Identifier Type: -

Identifier Source: org_study_id