Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Infarct size and microvascular obstruction assessed by MRI
研究概览
简要总结
Prehospital initiated facilitation of primary percutaneous coronary intervention by fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous coronary intervention.
This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.
详细描述
Patients with STEMI with symptoms < 3 hours are randomized in the region of Leipzig to either prehospital full-dose fibrinolysis (+ASA, Clopidogrel and heparin) with subsequent facilitated percutaneous coronary intervention or to primary percutaneous coronary intervention (after ASA + heparin + clopidogrel).
Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.
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
- •Angina pectoris < 3 hours
- •ST-elevation myocardial infarction
排除标准
- •Active bleeding
- •Active gastric ulcus
- •Previous stroke
- •Uncontrolled hypertension (> 200 mmHg)
- •Cerebral surgery < 8 weeks
- •Major surgery < 4 weeks
- •Malignancy
- •Treatment with coumarines
- •Pregnancy
研究组 & 干预措施
Primary PCI
干预措施: Primary PCI (Procedure)
Prehospital facilitated PCI
干预措施: fibrinolysis (Drug)
结局指标
主要结局
Infarct size and microvascular obstruction assessed by MRI
时间窗: 1-6 days
次要结局
- ST-segment resolution(90 min)
- Clinical endpoints (bleeding, death, Re-MI, stroke)(30 days)