Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07683585

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypertension Cardiovascular Diseases Coronary Arterial Disease Percutaneous Coronary Intervention Vascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

Location status: Recruiting

Location contact

Oksana Drapkina

CONTACT

[email protected]

+7 (495) 212-07-13

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizaveta Rogozhkina

CONTACT

[email protected]

+7 (937) 104-73-31

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Acronym: EDAM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.