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

NCT07683585 | Recruiting

• 1 other identifier: 04-03/26
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antihypertensive Therapy; Blood Pressure Control; Percuraneous Coronary Intervention; Angiotensin Receptor Blocker; Calcium Channel Blocker; Thiazide Diuretic

Outcome Measures

Primary Outcomes (1)

• Change in office systolic and diastolic blood pressure (mmHg)

  Assessment of changes in systolic and diastolic blood pressure values compared with baseline measurements after initiation of dual antihypertensive therapy following elective percutaneous coronary intervention

  2 weeks, 4 weeks, and 12 weeks after hospital discharge

Secondary Outcomes (3)

• Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)

  2 weeks, 4 weeks, and 12 weeks after hospital discharge

• Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)

  2 weeks, 4 weeks, and 12 weeks after hospital discharge

• Participants requiring healthcare utilization during follow-up

  2 weeks, 4 weeks, and 12 weeks after hospital discharge

Study Arms (2)

ARB + Thiazide Diuretic

ACTIVE COMPARATOR

Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention.

Drug: Losartan + Hydrochlorothiazide

ARB + Calcium Channel Blocker

ACTIVE COMPARATOR

Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention.

Drug: Amlodipine + Azilsartan

Interventions

Losartan + Hydrochlorothiazide DRUG

Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.

ARB + Thiazide Diuretic

Amlodipine + Azilsartan DRUG

Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.

ARB + Calcium Channel Blocker

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination; Amlodipine; azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Olga Dzhioeva

  National Medical Research Center for Therapy and Preventive Medicine

  STUDY CHAIR

• Oxana Drapkina

  National Medical Research Center for Therapy and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizaveta Rogozhkina

CONTACT

+7 (937) 104-73-31; lizarogozkina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two parallel treatment groups. One group will receive an angiotensin receptor blocker combined with a thiazide diuretic, and the other group will receive an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker. Outcomes will be assessed at 2, 4, and 12 weeks after hospital discharge.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: July 6, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)