Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,016
- 试验地点
- 85
- 主要终点
- Composite of all-cause death or BARC type 3~5 bleeding
研究概览
简要总结
This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI 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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
- •Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
- •Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
- •The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.
排除标准
- •Not suitable for emergency primary PCI;
- •STEMI treated by thrombolysis;
- •Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
- •Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
- •Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
- •Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
研究组 & 干预措施
Bivalirudin
Bivalirudin with prolonged full dose infusion during primary PCI
干预措施: Bivalirudin (Drug)
Heparin
Heparin alone during primary PCI
干预措施: unfractionated Heparin (Drug)
结局指标
主要结局
Composite of all-cause death or BARC type 3~5 bleeding
时间窗: 30 days
BARC=Bleeding academic research consortium
次要结局
- BARC type 2-5 bleeding(30 days)
- Stent thrombosis(30 days)
- Thrombocytopenia(30 days)
- All cause mortality(1 years)
- BARC type 3-5 bleeding(30 days)
- Major adverse cardiac and cerebral events (MACE)(30 days)
- Net adverse clinical events (NACE)(30 days)
- Composite of all-cause death or BARC type 2-5 bleeding(30 days)
研究者
Han Yaling
Director
Shenyang Northern Hospital