Very Early Initiation of Treatment With Thrombolysis and Low Molecular Weight Heparin, Versus Abciximab and Low Molecular Weight Heparin Followed by Percutaneous Coronary Intervention, for Acute ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 5
- 主要终点
- Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
研究概览
简要总结
The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.
详细描述
Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.
Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).
Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.
Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.
排除标准
- •BP >180/110
- •Known bleeding disorder
- •Cardiogenic shock
- •CPR>10 min
- •Ongoing anticoagulant therapy
- •Renal insufficiency
- •Weight >120 kg
研究组 & 干预措施
thrombolysis
干预措施: reteplase 10+10 U (Drug)
invasive
干预措施: primary PCI (Procedure)
结局指标
主要结局
Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
时间窗: 120 minutes after inclusion
ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
时间窗: 5-7 days after inclusion
Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
次要结局
- Death(30 days)
- Reinfarction(30 days)
- Stroke(30 days)