Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Change in office systolic and diastolic blood pressure (mmHg)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in office systolic and diastolic blood pressure (mmHg)
时间窗: 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
次要结局
- Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)(2 weeks, 4 weeks, and 12 weeks after hospital discharge)
- Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)(2 weeks, 4 weeks, and 12 weeks after hospital discharge)
- Participants requiring healthcare utilization during follow-up(2 weeks, 4 weeks, and 12 weeks after hospital discharge)