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

An observational study of Coronary Artery Disease and Myocardial Infarction, run by Servier Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease, Myocardial Infarction, Arterial Hypertension
What is being tested?: in daily everyday routine practice
Type of treatment: Pill or oral medicine
How many people: 504 participants
Where: 1 siteRussia
Study dates: 1 Mar 2021to 18 Oct 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: CAD patients with previous MI and HTN

Who may be able to join

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

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Peoples' Friendship University of Russia
Moscow

Other trials in Russia

About this study

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

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.

Read the detailed description

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
Being tested: in daily everyday routine practice
Medical subject headings: Coronary Artery Disease, Myocardial Infarction, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

in daily everyday routine practiceDrug
Also called 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.
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (14)

Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline.
Change in mean systolic and diastolic BP levels at week 4 of treatment with SPC compared with baseline.
Measured: 1 month
Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.
Change in number of angina attacks per week at week 4 of treatment compared with baseline.
Measured: 1 month
Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline
Change in number of angina attacks per week at week 12 of treatment compared with baseline.
Measured: 3 months
Proportion of Patients Who Were Taking Lipid Lowering Therapy
Proportion of patients who were taking lipid lowering therapy (LLT) at week 12 of treatment
Measured: 3 months
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 4.
Measured: 1 month
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline
Proportion of patients who achieved SBP ≤140 mm Hg and DBP ≤90 mm Hg at week 12
Measured: 3 months
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline
Proportion of patients younger than 65 who achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at week 4 of treatment
Measured: 1 month
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.
Measured: 3 months
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
Measured: 1 month
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
Measured: 3 months
Mean Heart Rate (HR) at Week 4 Compared With Baseline.
Changes in the mean heart rate (HR) at week 4 of treatment compared with baseline
Measured: 1 month
Mean Heart Rate (HR) at Week 12 Compared With Baseline.
Changes in the mean heart rate (HR) at week 12 of treatment compared with baseline
Measured: 3 months
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.
Measured: 1 month
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202118 Oct 2021

First posted7 Dec 2020
Study start1 Mar 2021
Primary completion5 Oct 2021
Study completion18 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04656847
Sponsor's protocol ID: IC4-05150-065-RUS
Acronym: PRIDE
Status last verified: Aug 2024
First submitted: 30 Nov 2020
Last updated: 1 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37029871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04656847
Acronym / sponsor ID: PRIDE / IC4-05150-065-RUS
Conditions: Coronary Artery Disease, Myocardial Infarction, Arterial Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 504 participants (actual)
Lead sponsor: Servier RussiaIndustry (pharma, biotech, devices)
Study start: 1 Mar 2021 (actual)
Primary completion: 5 Oct 2021 (actual)
Study completion: 18 Oct 2021 (actual)
First posted: 7 Dec 2020 (actual)
Results: Posted 1 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Other

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: CAD patients with previous MI and HTN

Key inclusion criteria (4 listed)

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

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
in daily everyday routine practiceAlso: 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.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.	Drug	–

Primary outcome

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
Time frame: 3 months
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.

14 secondary outcomes

Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline.
Time frame: 1 month
Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline.
Time frame: 1 month
Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline
Time frame: 3 months
Proportion of Patients Who Were Taking Lipid Lowering Therapy
Time frame: 3 months
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline
Time frame: 1 month
SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline
Time frame: 3 months
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline
Time frame: 1 month
Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment
Time frame: 3 months
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment
Time frame: 1 month
Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment
Time frame: 3 months
Mean Heart Rate (HR) at Week 4 Compared With Baseline.
Time frame: 1 month
Mean Heart Rate (HR) at Week 12 Compared With Baseline.
Time frame: 3 months
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4
Time frame: 1 month
Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12
Time frame: 3 months

Results and safety

Results posted to the registry on 1 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAD Patients With Previous MI and HTN	504	504

Primary outcome: 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

Time frame: 3 months. Mean (Standard Deviation). Unit: mm Hg

Measure	CAD Patients With Previous MI and HTN n = 481
SBP	-24.92 (16.43)
DBP	-12.21 (11.03)

Population analysed: 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

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAD Patients With Previous MI and HTN	0 of 504 (0%)	0 of 504 (0%)	0 of 504

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37029871Kobalava 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhanna Kobalava, Professor principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Infarction, run by Servier Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04656847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.