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

Coronary Artery Disease Clinical Trial

— PRIDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656847
• Other study ID #: IC4-05150-065-RUS
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: October 18, 2021

Study information

• Verified date: January 2022
• Source: Servier Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: October 18, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Coronary Artery Disease
• Hypertension
• Infarction
• Myocardial Infarction

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Russian Federation	Peoples' Friendship University of Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antihypertensive effectiveness (SBP and DBP reduction) of bisoprolol/perindopril SPC in CAD patients with previous MI and HTN at week 12 of treatment	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	Change in mean systolic and diastolic BP levels at week 4	Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline.	1 month
Secondary	Change in number of angina attacks per week at week 4	Change in number of angina attacks per week at week 4 of treatment compared with baseline.	1 month
Secondary	Change in number of angina attacks per week at week 12	Change in number of angina attacks per week at week 12 of treatment compared with baseline.	3 months
Secondary	Proportion of patients who were taking lipid lowering therapy	Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment	3 months
Secondary	Proportion of patients receiving LLT who achieved target levels of LDL	Proportion of patients receiving LLT who achieved target levels of LDL C at week 12 of treatment.	3 months
Secondary	SBP =140 mm Hg and DBP =90 mm Hg at week 4.	Proportion of patients who achieved SBP =140 mm Hg and DBP =90 mm Hg at week 4.	1 month
Secondary	SBP =140 mm Hg and DBP =90 mm Hg at week 12	Proportion of patients who achieved SBP =140 mm Hg and DBP =90 mm Hg at week 12	3 months
Secondary	Younger than 65 who achieved SBP =130 mm Hg and DBP =80 mm Hg at week 4 of treatment	Proportion of patients younger than 65 who achieved SBP =130 mm Hg and DBP =80 mm Hg at week 4 of treatment	1 month
Secondary	younger than 65 who achieved SBP =130 mm Hg and DBP =80 mm Hg at week 12 of treatment	Proportion of patients younger than 65 who achieved SBP =130 mm Hg and DBP =80 mm Hg at week 12 of treatment.	3 months
Secondary	older than 65 years who achieved SBP=140 mm Hg and DBP =90 mm Hg at week 4 of treatment	Proportion of patients older than 65 years who achieved SBP=140 mm Hg and DBP =90 mm Hg at week 4 of treatment	1 month
Secondary	older than 65 years who achieved SBP=140 mm Hg and DBP =90 mm Hg at week 12 of treatment	Proportion of patients older than 65 years who achieved SBP=140 mm Hg and DBP =90 mm Hg at week 12 of treatment	3 months
Secondary	mean heart rate (HR) at week 4	Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline	1 month
Secondary	mean heart rate (HR) at week 12	Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline	3 months
Secondary	patients who achieved target level of resting HR (55-60 bpm) at week 4	Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 4 of treatment.	1 month
Secondary	patients who achieved target level of resting HR (55-60 bpm) at week 12	Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 12 of treatment.	3 months
Secondary	Changes in the quality of life assessed by Health Questionnaire EuroQol (EQ-5D-5L) at week 4	Changes in the quality of life assessed by Health Questionnaire EuroQol (abbreviated as EQ-5D-5L, scale is numbered from 0 to 100; 100 means the best health; 0 means the worst health) at week 4 of treatment compared with baseline	1 month
Secondary	Changes in the quality of life assessed by Health Questionnaire EuroQol (EQ-5D-5L) at week 12	Changes in the quality of life assessed by Health Questionnaire EuroQol (abbreviated as EQ-5D-5L, scale is numbered from 0 to 100; 100 means the best health; 0 means the worst health) at week 12 of treatment compared with baseline	3 month