Southwest German Interventional Study in Acute Myocardial Infarction III
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.
详细描述
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of MI present for 12 h
- •ST segment elevation of at least 1 mm in two or more limb leads,
- •ST segment elevation of at least 2 mm in the precordial leads,
- •or new bundlebranch block
- •Patients eligible for thrombolysis
- •Informed consent for participation
排除标准
- •Secondary or iatrogenic infarction
- •Chronic renal insufficiency requiring dialysis
- •Coronary anatomy unsuitable for stent placement
- •Anticipated indication for surgical coronary revascularization within 6 months
- •Previous MI in the area of the infarct related vessel
- •Infarct related lesion not clearly defined
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 6 months
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
次要结局
- Reinfarction(6 months)
- Ischemic Events(6 months)
- Target Vessel Revascularization(6 months)
- Death(6 months)