Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Net Adverse Clinical Events
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
详细描述
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 80 years old
- •Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB)
- •Provide written informed consent.
排除标准
- •Age <18 or >80 years.
- •Any anticoagulant drugs were regularly used within 3 months.
- •Any anticoagulant agents were used 48 h before randomization.
- •Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.
- •Hemoglobin < 90 g/L or platelet count < 100 * 109 / L.
- •Untreated or uncontrolled hypertension > 180/110 mmHg.
- •Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
- •Heparin induced thrombocytopenia.
- •Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
- •Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- •Pregnancy , lactation or plan to be pregnant.
- •Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months.
- •Unsuitable for PCI.
- •Attended any clinical trial 1 month before randomised.
研究组 & 干预措施
Bivalirudin
Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.
干预措施: Bivalirudin (Drug)
Heparin monotherapy
100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
干预措施: heparin (Drug)
结局指标
主要结局
Net Adverse Clinical Events
时间窗: 30 days
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
次要结局
- Major adverse cardiac events (MACE)(30 days)
- Any bleedings (BARC class)(30 days)