Coronary Arterial Disease, Hypertension, Percutaneous Coronary Intervention
Conditions
Keywords
Antihypertensive Therapy, Blood Pressure Control, Percuraneous Coronary Intervention, Angiotensin Receptor Blocker, Calcium Channel Blocker, Thiazide Diuretic
Brief summary
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
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
DRUGAmlodipine + Azilsartan
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
Sponsors
National Medical Research Center for Therapy and Preventive Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into two parallel treatment groups. One group will receive an angiotensin receptor blocker combined with a thiazide diuretic, and the other group will receive an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker. Outcomes will be assessed at 2, 4, and 12 weeks after hospital discharge.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in office systolic and diastolic blood pressure (mmHg) | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Limitation Score of the Seattle Angina Questionnaire (SAQ) | 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 |
| Angina Frequency Score of the Seattle Angina Questionnaire (SAQ) | 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 |
| Participants requiring healthcare utilization during follow-up | 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 |
Countries
Russia
Contacts
CONTACTElizaveta Rogozhkina
STUDY_CHAIROlga Dzhioeva
National Medical Research Center for Therapy and Preventive Medicine
PRINCIPAL_INVESTIGATOROxana Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Outcome results
None listed