Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,194
- 试验地点
- 81
- 主要终点
- Net Adverse Clinical Events
研究概览
简要总结
The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.
All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
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 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. 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 (Outcomes Assessor)
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
- 否
入选标准
- •Age 18 to 80 years old
- •Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI
- •Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
- •Provide written informed consent.
排除标准
- •Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
- •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.;
- •Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
- •Deep puncture or major surgery (including eye or brain surgery) within 1 month.
- •Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
- •Untreated or uncontrolled hypertension > 180/110 mmHg.
- •Hemoglobin < 100 g/L or platelet count < 100 * 109 / L.
- •Elevated AST, ALT level higher than three times of the normal upper limit.
- •severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
- •Heparin induced thrombocytopenia.
- •Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- •Pregnancy or lactation.
- •Researchers think that doesn't fit to participate in this study.
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)
heparin plus tirofiban
heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
干预措施: heparin (Drug)
heparin plus tirofiban
heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
干预措施: heparin plus tirofiban (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 and cerebral events (MACCE)(30 days and 1 year)
- any bleedings (BARC class)(30 day)
- Net adverse clinical events(1 year)
研究者
Han Yaling
director of the department of cardiology
Shenyang Northern Hospital