N/A
Completed N=504
PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril
Source: ClinicalTrials.gov NCT04656847 ↗Enrolled (actual)
504
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: 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 — -24.92; -12.21 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-24.92; -12.21 | — |
| SECONDARY Change in Mean Systolic and Diastolic BP Levels at Week 4 Compared With Baseline. |
-17.32; -8.39 | — |
| SECONDARY Change in Number of Angina Attacks Per Week at Week 4 Compared With Baseline. |
2.76 | — |
| SECONDARY Change in Number of Angina Attacks Per Week at Week 12 Compared With Baseline |
0.95 | — |
| SECONDARY Proportion of Patients Who Were Taking Lipid Lowering Therapy |
397 | — |
| SECONDARY SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 4 Compared With Baseline |
330 | — |
| SECONDARY SBP ≤140 mm Hg and DBP ≤90 mm Hg at Week 12 Compared With Baseline |
417 | — |
| SECONDARY Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 4 of Treatment Compared With Baseline |
86 | — |
| SECONDARY Younger Than 65 Who Achieved SBP ≤130 mm Hg and DBP ≤80 mm Hg at Week 12 of Treatment |
143 | — |
| SECONDARY Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 4 of Treatment |
109 | — |
| SECONDARY Older Than 65 Years Who Achieved SBP≤140 mm Hg and DBP ≤90 mm Hg at Week 12 of Treatment |
162 | — |
| SECONDARY Mean Heart Rate (HR) at Week 4 Compared With Baseline. |
-10.87 | — |
| SECONDARY Mean Heart Rate (HR) at Week 12 Compared With Baseline. |
-14.44 | — |
| SECONDARY Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 4 |
82 | — |
| SECONDARY Patients Who Achieved Target Level of Resting HR (55-60 Bpm) at Week 12 |
150 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04656847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.