Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,770
- 试验地点
- 1
- 主要终点
- creatine kinase-MB increase
研究概览
简要总结
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
详细描述
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
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
- None
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
- •Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.
排除标准
- •cardiogenic shock;
- •thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
- •active or recent major bleeding or bleeding predisposition;
- •major surgery within 1 month;
- •clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
- •blood pressure higher than 180/110 mm Hg;
- •known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min;
- •history of heparin-induced thrombocytopenia;
- •allergy to any of the study drugs or devices;
- •pregnancy or lactation;
- •any condition making PCI unsuitable or that might interfere with study adherence; and
- •patient unwilling or unable to provide written informed consent.
研究组 & 干预措施
heparin
For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines.
干预措施: Heparin (Drug)
not prolong infusion Bivalirudin
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure .
干预措施: bivalirudin (Drug)
prolong infusion bivalirudin
Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure.
干预措施: bivalirudin (Drug)
结局指标
主要结局
creatine kinase-MB increase
时间窗: up to postprocedural 72 hours
creatine kinase-MB increase \>3 times upper limit of normal
次要结局
- major adverse cardiac or cerebral events(30 days and 1 year)
- bleeding（BARC class）(30 days and 1 year)
- Net Adverse Clinical Events(30 days and 1 year)
研究者
Yun Dai Chen
Chinese PLA General Hospital
Chinese PLA General Hospital