Recruiting

Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention

ClinicalTrials.gov IDNCT07683585

PhaseNA

Enrollment207

SponsorNational Medical Research Center for Therapy and Preventive Medicine

Age50 Years

SexALL

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Conditions studied

Hypertension, Coronary Arterial Disease, Percutaneous Coronary Intervention

About this study

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.

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.

Primary outcomes

Change in office systolic and diastolic blood pressure (mmHg) (2 weeks, 4 weeks, and 12 weeks after hospital discharge)

Eligibility information

Inclusion Criteria: * Age 50 to 70 years * Arterial hypertension * Coronary artery disease * Hospitalization for elective percutaneous coronary intervention * Coronary artery stenting during the current hospitalization * Requirement for dual antihypertensive therapy * Treatment with beta-blockers, lipid-lowering therapy, and antiplatelet therapy * Ability and willingness to provide written informed consent Exclusion Criteria: * Refusal or inability to provide informed consent * Acute coronary syndrome * Active malignancy * Pulmonary embolism * Chronic kidney disease stage 4-5 * Type 2 diabetes mellitus * Contraindications or intolerance to study medications, including bilateral renal artery stenosis, hyperkalemia, hyperuricemia, or gout * Women of reproductive age * Permanent or persistent atrial fibrillation * Planned staged coronary stenting * Heart failure with reduced ejection fraction * Any other condition that, in the investigator's opinion, may interfere with participation in the study or interpretation of study results

Study locations

National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.