Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention
NCT07683585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2026-07-06
Summary
This prospective randomized open-label study aims to compare the effectiveness of two dual antihypertensive therapy regimens in patients with arterial hypertension and coronary artery disease after elective percutaneous coronary intervention (PCI) with coronary artery stenting.
Patients requiring dual antihypertensive therapy will be randomized to receive either an angiotensin receptor blocker (ARB) combined with a thiazide diuretic or an ARB combined with a dihydropyridine calcium channel blocker.
The study will evaluate blood pressure control, angina symptoms, quality of life, need for treatment intensification, and healthcare utilization during follow-up. Clinical status will be assessed at discharge and during telemedicine follow-up visits at 2 weeks, 4 weeks, and 12 weeks after hospital discharge.
The primary endpoint is the percentage reduction in systolic and diastolic blood pressure. Secondary endpoints include frequency of angina episodes, exercise limitations, patient satisfaction with treatment, and medical consultations during follow-up.
The study is investigator-initiated and plans to enroll at least 207 participants.
Conditions
- Hypertension
- Coronary Arterial Disease
- Percutaneous Coronary Intervention
Interventions
- DRUG
-
Losartan + Hydrochlorothiazide
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
- DRUG
-
Amlodipine + Azilsartan
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
Sponsors & Collaborators
-
National Medical Research Center for Therapy and Preventive Medicine
lead OTHER_GOV
Principal Investigators
-
Olga Dzhioeva · National Medical Research Center for Therapy and Preventive Medicine
-
Oxana Drapkina · National Medical Research Center for Therapy and Preventive Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2026-07-31
- Completion
- 2026-09-30
Countries
- Russia
Study Locations
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