An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,031
- 试验地点
- 1
- 主要终点
- Composite of Death, Myocardial (re-) Infarction, or Stroke
研究概览
简要总结
The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation) i.e., clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain)
- •Able to randomise within 24 hours of the onset of the most recent episode of symptoms
- •At least two of the three following additional criteria:
- •Age more than or equal to 60 years
- •Troponin T or I or Creatine Kinase - Myocardial Bands (CK-MB) above the upper limit of normal for the local institution
- •ElectroCardioGram (ECG) changes compatible with ischemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation)
- •Written informed consent dated and signed
排除标准
- •Age less than 21 years
- •Not a suitable candidate for revascularisation
- •Co-morbid condition with life expectancy less than six months
研究组 & 干预措施
Early Coronary Intervention
Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
干预措施: Early Coronary Intervention (Procedure)
Delayed Coronary Intervention
Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
干预措施: Delayed Coronary Intervention (Procedure)
结局指标
主要结局
Composite of Death, Myocardial (re-) Infarction, or Stroke
时间窗: 180 days
次要结局
- First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia(180 days)
- Stroke at 30 Days and 180 Days(180 days)
- Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180(180 days)
- In-hospital Major Bleeding(Hospital discharge)
- Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days(180 days)