Clinical trial NCT04656847: PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril
Official title: Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/PerindopRil In Patients With Previous Myocardial Infraction With Arterial Hypertension in the Daily Clinical practicE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Infarction
Arterial Hypertension
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CAD patients with previous MI and HTN

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.

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.

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline.
timeFrame: 1 month
measure: Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.
timeFrame: 1 month
measure: Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline
timeFrame: 3 months
measure: Proportion of Patients Who Were Taking Lipid Lowering Therapy
timeFrame: 3 months
measure: SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline
timeFrame: 1 month
measure: SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline
timeFrame: 3 months
measure: Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline
timeFrame: 1 month
measure: Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment
timeFrame: 3 months
measure: Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment
timeFrame: 1 month
measure: Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment
timeFrame: 3 months
measure: Mean Heart Rate (HR) at Week 4 Compared With Baseline.
timeFrame: 1 month
measure: Mean Heart Rate (HR) at Week 12 Compared With Baseline.
timeFrame: 3 months
measure: Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4
timeFrame: 1 month
measure: Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Peoples' Friendship University of Russia
Study officials:
name: Zhanna Kobalava, Professor
role: PRINCIPAL_INVESTIGATOR
References: