Trial Outcomes & Findings for PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril (NCT NCT04656847)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

504 participants

Primary outcome timeframe

3 months

Results posted on

2024-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	CAD Patients With Previous MI and HTN Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
1 Month After Inclusion STARTED	504
1 Month After Inclusion Lipid Lowering Therapy	463
1 Month After Inclusion COMPLETED	504
1 Month After Inclusion NOT COMPLETED	0
3 Month After Inclusion STARTED	504
3 Month After Inclusion 3 Month After Inclusion	504
3 Month After Inclusion Lipid Lowering Therapy	463
3 Month After Inclusion COMPLETED	481
3 Month After Inclusion NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	CAD Patients With Previous MI and HTN Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
3 Month After Inclusion lack of data on myocardial infarction and/or data by visits	23

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Age, Continuous	61.38 years STANDARD_DEVIATION 8.87 • n=481 Participants
Sex: Female, Male Female	154 Participants n=481 Participants
Sex: Female, Male Male	327 Participants n=481 Participants
Region of Enrollment Russia	481 participants n=481 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Changes in the mean office systolic BP levels (in mm Hg) in the sitting position among the patients with HT and CAD recieved the biso/perindopril FDC

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.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
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 SBP	-24.92 mm Hg Standard Deviation 16.43
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 DBP	-12.21 mm Hg Standard Deviation 11.03

SECONDARY outcome

Timeframe: 1 month

Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. Systolic BP	-17.32 mm Hg Standard Deviation 13.97
Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. Dyastolic BP	-8.39 mm Hg Standard Deviation 8.79

SECONDARY outcome

Timeframe: 1 month

Change in number of angina attacks per week at week 4 of treatment compared with baseline.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.	2.76 angina attacks per week Standard Deviation 2.26

SECONDARY outcome

Timeframe: 3 months

Change in number of angina attacks per week at week 12 of treatment compared with baseline.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline	0.95 angina attacks per week Standard Deviation 0.94

SECONDARY outcome

Timeframe: 3 months

Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=463 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Proportion of Patients Who Were Taking Lipid Lowering Therapy	397 Number of Participants Who Were Taking L

SECONDARY outcome

Timeframe: 1 month

Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline	330 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 12

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline	417 Participants

SECONDARY outcome

Timeframe: 1 month

Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 4 of treatment

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=295 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline	86 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 12 of treatment.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=293 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment	143 Participants

SECONDARY outcome

Timeframe: 1 month

Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 4 of treatment

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=186 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment	109 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients older than 65 years who achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at week 12 of treatment

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=186 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment	162 Participants

SECONDARY outcome

Timeframe: 1 month

Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Mean Heart Rate (HR) at Week 4 Compared With Baseline.	-10.87 beats per minute Standard Deviation 10.36

SECONDARY outcome

Timeframe: 3 months

Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Mean Heart Rate (HR) at Week 12 Compared With Baseline.	-14.44 beats per minute Standard Deviation 11.69

SECONDARY outcome

Timeframe: 1 month

Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 4 of treatment.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4	82 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients who achieved target level of resting HR (55-60 bpm) at week 12 of treatment.

Outcome measures

Outcome measures
Measure	CAD Patients With Previous MI and HTN n=481 Participants Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12	150 Participants

Adverse Events

CAD Patients With Previous MI and HTN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical manager - Yuriy Burtsev

Sevier

Phone: 8-495-93707-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place