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

NCT07683585 — Not applicable, Recruiting, 207 participants, National Medical Research Center for Therapy and Preventive Medicine

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Registry	NCT07683585, acronym EDAM
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	207 (Estimated)
Sponsor	National Medical Research Center for Therapy and Preventive Medicine (Other gov)
Conditions	Hypertension, Coronary Arterial Disease, Percutaneous Coronary Intervention
Interventions	Losartan + Hydrochlorothiazide, Amlodipine + Azilsartan (Drug)
Dates	start 2026-04-01, primary completion 2026-07-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-07-06, last updated 2026-07-06
Locations	1 site in Russia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ARB + Thiazide Diuretic	Active comparator	Drug: Losartan + Hydrochlorothiazide	Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention.
ARB + Calcium Channel Blocker	Active comparator	Drug: Amlodipine + Azilsartan	Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention.

Losartan + Hydrochlorothiazide (Drug): Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Physical Limitation Score of the Seattle Angina Questionnaire (SAQ) [2 weeks, 4 weeks, and 12 weeks after hospital discharge]: Assessment of exercise limitation using the Physical Limitation domain of the Seattle Angina Questionnaire (SAQ). Scores range from 0 to 100, with higher scores indicating less physical limitation and better functional status
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ) [2 weeks, 4 weeks, and 12 weeks after hospital discharge]: Assessment of angina frequency using the Angina Frequency domain of the Seattle Angina Questionnaire (SAQ). Scores range from 0 to 100, with higher scores indicating fewer angina episodes and better angina control
Participants requiring healthcare utilization during follow-up [2 weeks, 4 weeks, and 12 weeks after hospital discharge]: Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
National Medical Research Center for Therapy and Preventive Medicine	Moscow	Russia	Recruiting

+Investigators

Olga Dzhioeva, Study chair, National Medical Research Center for Therapy and Preventive Medicine
Oxana Drapkina, Principal investigator, National Medical Research Center for Therapy and Preventive Medicine