2024-516039-28-00招募中4 期
Randomized clinical trial assessing the value of Beta-Blockers and Antiplatelet Agents in patients with Spontaneous Coronary Artery Dissection (BA-SCAD).
Spanish Society Of Cardiology, Spanish Society Of Cardiology, Spanish Society Of Cardiology60 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年7月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 60
- 主要终点
- A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.
研究概览
简要总结
To assess the efficacy of medical therapy (β-blockers and antiplatelet agents) in patients with Spontaneous Coronary Artery Dissection (SCAD).
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized controlled pragmatic trial using a 2x2 factorial design. Low-intervention clinical trial.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Patients admitted for ACS or any other manifestation of myocardial ischemia.
- •Diagnosis of SCAD on a coronary angiography during index hospitalization.
排除标准
- •Cardiogenic shock or severe hemodynamic instability.
- •Concomitant severe heart disease requiring surgical correction (in <2 years).
- •Any major medical condition seriously limiting life expectancy (<2 years).
- •Pregnant or breastfeeding women. Child-bearing age women participating in the study will be advised to use a highly effective contraceptive method considering the high-risk of recurrent SCAD associated with pregnancy.
- •Participation in another clinical trial.
结局指标
主要结局
A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.
A combined clinical endpoint including death, MI, stroke, coronary revascularization, recurrent dissection and hospital admission for ACS or heart failure at 1-year follow-up.
次要结局
- a secondary combined clinical endpoint (composite of death, MI, stroke, coronary revascularization, and recurrent dissection, hospital admission for ACS –with dynamic ECG changes- or heart failure or bleeding) will be used to assess the “net clinical benefit” of the antiplatelet strategy.
- Bleeding will be also analyzed as a separate safety secondary endpoint. Bleeding will be defined according to BARC definitions.
- Individual components of the primary endpoint will be assessed as secondary endpoints. Besides, a major predefined secondary combined endpoint will be the composite outcome measure of “hard” clinical events (including death, MI, stroke, recurrent dissection and coronary revascularization) and the combined outcome measure of death and MI alone.
研究者
Fernando Alfonso
Scientific
Spanish Society Of Cardiology
研究点 (60)
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