Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary Intervention (EDAM)
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Elizaveta Rogozhkina
- 电话号码：+7 (937) 104-73-31
- 邮箱：lizarogozkina@gmail.com
学习地点
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Moscow、俄罗斯
- 招聘中
- National Medical Research Center for therapy and preventive medicine
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接触：
- Oksana Drapkina
- 电话号码：+7 (495) 212-07-13
- 邮箱：drapkina@bk.ru
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：ARB + Thiazide Diuretic
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic after elective percutaneous coronary intervention.
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Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a thiazide diuretic administered after elective percutaneous coronary intervention.
|
|
有源比较器：ARB + Calcium Channel Blocker
Participants will receive dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker after elective percutaneous coronary intervention.
|
Dual antihypertensive therapy consisting of an angiotensin receptor blocker combined with a dihydropyridine calcium channel blocker administered after elective percutaneous coronary intervention.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in office systolic and diastolic blood pressure (mmHg)
大体时间：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
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Limitation Score of the Seattle Angina Questionnaire (SAQ)
大体时间：2 weeks, 4 weeks, and 12 weeks after hospital discharge
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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
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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|
Angina Frequency Score of the Seattle Angina Questionnaire (SAQ)
大体时间：2 weeks, 4 weeks, and 12 weeks after hospital discharge
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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
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
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|
Participants requiring healthcare utilization during follow-up
大体时间：2 weeks, 4 weeks, and 12 weeks after hospital discharge
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Number of participants requiring at least one outpatient visit, emergency department visit, or hospitalization during follow-up
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2 weeks, 4 weeks, and 12 weeks after hospital discharge
|
合作者和调查者
调查人员
- 首席研究员：Oxana Drapkina、National Medical Research Center for therapy and preventive medicine
- 学习椅：Olga Dzhioeva、National Medical Research Center for therapy and preventive medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 04-03/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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