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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorNational Medical Research Center for Therapy and Preventive Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 to 70 years

Arterial hypertension

Coronary artery disease

Hospitalization for elective percutaneous coronary intervention

Disqualifiers

Refusal or inability to provide informed consent

Acute coronary syndrome

Active malignancy

Pulmonary embolism

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

207 Participants
are divided into 2 treatment groups
Group A: ARB + Thiazide DiureticActive comparator 1 intervention
Group B: ARB + Calcium Channel BlockerActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)

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

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

Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)

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

Time frame
2 weeks, 4 weeks, and 12 weeks after hospital discharge
3

Participants requiring healthcare utilization during follow-up

Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.