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

June 27, 2026 updated by: National Medical Research Center for Therapy and Preventive Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia
        • Recruiting
        • National Medical Research Center for Therapy and Preventive Medicine
        • Contact:
          • Oksana Drapkina
          • Phone Number: +7 (495) 212-07-13
          • Email: drapkina@bk.ru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARB + Thiazide Diuretic
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
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
Active Comparator: ARB + Calcium Channel Blocker
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
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in office systolic and diastolic blood pressure (mmHg)
Time Frame: 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
2 weeks, 4 weeks, and 12 weeks after hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
Time Frame: 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
2 weeks, 4 weeks, and 12 weeks after hospital discharge
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
Time Frame: 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
2 weeks, 4 weeks, and 12 weeks after hospital discharge
Participants requiring healthcare utilization during follow-up
Time Frame: 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
2 weeks, 4 weeks, and 12 weeks after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Investigators

  • Principal Investigator: Oxana Drapkina, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Olga Dzhioeva, National Medical Research Center for Therapy and Preventive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 27, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-03/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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