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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARB + Thiazide Diuretic | Active Comparator | Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention. |
|
| ARB + Calcium Channel Blocker | Active Comparator | Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan + Hydrochlorothiazide | Drug | Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks, 4 weeks, and 12 weeks after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks, 4 weeks, and 12 weeks after hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizaveta Rogozhkina | Contact | +7 (937) 104-73-31 | lizarogozkina@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Olga Dzhioeva | National Medical Research Center for Therapy and Preventive Medicine | Study Chair |
| Oxana Drapkina | National Medical Research Center for Therapy and Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Therapy and Preventive Medicine | Recruiting | Moscow | Russia |
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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.
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| 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. |
|
| 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 | 2 weeks, 4 weeks, and 12 weeks after hospital discharge |
| Participants requiring healthcare utilization during follow-up | Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up | 2 weeks, 4 weeks, and 12 weeks after hospital discharge |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
| D017311 | Amlodipine |
| C521273 | azilsartan |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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