Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Losartan + Hydrochlorothiazide, Amlodipine + Azilsartan.
- Who it may be relevant to
- Registry conditions: Hypertension, Coronary Arterial Disease, Percutaneous Coronary Intervention. Basic parameters: 50 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Losartan + Hydrochlorothiazide
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered 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.
Primary outcome measures
- Change in office systolic and diastolic blood pressure (mmHg) [Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge]
Secondary outcome measures (3)
- Physical Limitation Score of the Seattle Angina Questionnaire (SAQ) [Time frame: 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]
- Participants requiring healthcare utilization during follow-up [Time frame: 2 weeks, 4 weeks, and 12 weeks after hospital discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- National Medical Research Center for Therapy and Preventive Medicine — Moscow
Identifiers
NCT: NCT07683585 · 04-03/26