Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- TIMI flow
研究概览
简要总结
Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention.
Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.
详细描述
Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight.
The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality.
Investigators plan to randomize 600 patients.
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)
盲法说明
Interventional cardiologists evaluating coronary angiography will be blinded to assigned group
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
- •Adult patients with STEMI referred for primary PCI
- •Duration of symptoms less than 6 hours before presentation
排除标准
- •Pregnancy
- •Cardiogenic shock at presentation (hemodynamic instability)
- •Cardiac arrest before randomization
- •Duration of symptoms for more than 6 hours before presentation
研究组 & 干预措施
Early unfractionated heparin
Administration of UFH at a dose of 100 IU/kg body weight at first medical contact. Addition of UFH before coronary intervention according to ACT measurement after coronary angiography before coronary intervention.
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
TIMI flow
时间窗: Day 0
TIMI flow in culprit coronary artery at first coronary angiography
次要结局
- Bleeding(Day 0)
- Troponin I concentration 24 h after primary PCI(24 h)
- Cardiogenic shock(Day 0 to 10)
- 30 day mortality after STEMI(30 days)
研究者
Peter Radsel
Head of intensive internal medicine department
University Medical Centre Ljubljana