Carvedilol Post-intervention Long-term Administration in Large-scale Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 801
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.
详细描述
Beta-blocker therapy is recommended after ST-segment elevation acute myocardial infarction (STEMI) in the current guidelines although its efficacy in those patients who have undergone primary percutaneous coronary intervention (PCI) has not been adequately evaluated. The purpose of this study is to evaluate whether beta-blocker, carvedilol improves 6-year clinical outcomes in patients with STEMI and preserved left ventricular ejection fraction after primary PCI. The design of this study is multicenter, open-label, randomized controlled trial enrolling 1300 patients without any exclusion criteria.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with STEMI after primary PCI
- •Patients with left ventricular ejection fraction more than or equal to 40%
排除标准
- •Patients with left ventricular ejection fraction less than 40%
- •Patients with contraindication for beta-blocker
- •Patients with implantable cardioverter defibrillators
- •Patients with end-stage malignancy
研究组 & 干预措施
Beta-blocker
Use of Carvedilol with any dose
干预措施: Carvedilol (Drug)
Non Beta-blocker
No use of Carvedilol
干预措施: No Carvedilol (Drug)
结局指标
主要结局
All cause mortality
时间窗: 6-year
Death from any reason
Composite of death, myocardial infarction, acute coronary syndrome, heart failure hospitalization
时间窗: 6-year
次要结局
- Cardiac death(6-year)
- Sudden cardiac death(6-year)
- Heart failure hospitalization(6-year)
- Target-vessel revascularization(6-year)
- Clinically-driven target-lesion revascularization(6-year)
- Any coronary revascularization(6-year)
- Any clinically-driven coronary revascularization(6-year)
- Coronary artery bypass grafting(6-year)
- Sustained ventricular tachycardia or ventricular fibrillation(6-year)
- Cardiovascular death(6-year)
- Acute coronary syndrome(6-year)
- Myocardial infarction(6-year)
- Stent thrombosis(6-year)
- Stroke(6-year)
- Worsening of angina due to coronary spasm(6-year)
- Bleeding complications(6-year)
- Composite of death, myocardial infarction, stroke, acute coronary syndrome, heart failure hospitalization, any coronary revascularization(6-year)
- Composite of cardiac death, myocardial infarction, acute coronary syndrome, heart failure hospitalization(6-year)
- Composite of cardiovascular death, myocardial infarction, stroke(6-year)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine