NCT02790528撤回4 期
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
Seung-Jung Park1 个研究点 分布在 1 个国家开始时间: 2017年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
研究概览
简要总结
The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 and more
- •Vasospastic angina
- •LDL less than 160mg/dl
- •Written consent
排除标准
- •Coronary artery stenosis more than 50% or ischemic coronary disease
- •History of percutaneous coronary intervention
- •Cerebrovascular diseases or peripheral
- •Dyslipidemia required statin therapy
- •Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
- •NYHA III and IV
- •Arrhythmia
- •Primary cardiac electrical diseases
- •Cardiac pacemaker or implantable defibrillator
- •Pregnancy or breast feeding
- •Life expectancy less than 2 years
研究组 & 干预措施
Atorvastatin
Experimental
20mg QD
干预措施: Atorvastatin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
时间窗: 3 years
The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)
次要结局
- cardiac death(3 years)
- statin-related complications(3 years)
- all-cause death(3 years)
- cardiac arrest(3 years)
- myocardial infarction(3 years)
- angina-related hospitalization(3 years)
- Composite event of death or myocardial infarction(3 years)
- Composite event of cardiac death or myocardial infarction(3 years)
研究者
Seung-Jung Park
professor of medicine
Asan Medical Center
研究点 (1)
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