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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Losartan + Hydrochlorothiazide
DrugDual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
Amlodipine + Azilsartan
DrugDual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
Participants requiring healthcare utilization during follow-up
Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up
Sponsors and contacts
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