Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 548
- 试验地点
- 3
- 主要终点
- composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
研究概览
简要总结
Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.
详细描述
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The benefit in reduction of ischemic complication was even greater in the subset of patients with STEMI without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting within 24 hours from the onset of symptoms with STEMI
- •Informed, written consent
- •In women with childbearing potential a pregnancy test is obligatory.
排除标准
- •Age < 18 years
- •Cardiogenic shock
- •Active bleeding; bleeding diathesis; coagulopathy
- •History of gastrointestinal or genitourinary bleeding <2 months
- •Refusal to receive blood transfusion
- •Major surgery in the last 6 weeks
- •History of intracranial bleeding or structural abnormalities
- •Suspected aortic dissection
- •Heparin-induced thrombocytopenia
- •Any previous stroke
- •Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
- •Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
- •Use of coumadin derivatives within the last 7 days
- •Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
- •Known malignancies or other comorbid conditions with life expectancy <1 year
- •Known severe liver disease, severe renal failure
- •Known allergy to the study medications
- •Previous enrollment in this trial
研究组 & 干预措施
Prasugrel + Bivalirudin
60 mg prasugrel plus bivalirudin
干预措施: Prasugrel (Drug)
Prasugrel + Bivalirudin
60 mg prasugrel plus bivalirudin
干预措施: Bivalirudin (Drug)
Clopidogrel + Heparin
clopidogrel as loading and heparin
干预措施: Clopidogrel (Drug)
Clopidogrel + Heparin
clopidogrel as loading and heparin
干预措施: Heparin (Drug)
结局指标
主要结局
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
时间窗: 30 days
次要结局
- all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis(30 days)
- major bleeding complications(30 days)
- cardiac death(30 days)