Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Major bleeding
研究概览
简要总结
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥75 years old;
- •Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients;
- •Life expectancy ≥ 1 year;
- •Provide written informed consent.
排除标准
- •Contraindications to angiography or PCI;
- •Active bleeding or bleeding constitution, bleeding tendency, including 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, intra-cerebral mass, aneurysm, etc.);
- •Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
- •Elevated AST, ALT level higher than three times of the normal upper limit;
- •Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ)
- •Complicated with immune system diseases；
- •Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white blood cell count < 3 * 109/L etc;
- •Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
- •Known intolerance, or contraindication to any antithrombotic medication
- •Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- •Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- •Patient's inability to fully cooperate with the study protocol
研究组 & 干预措施
Bivalirudin
Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
干预措施: Bivalirudin (Drug)
Heparin
Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
干预措施: Heparin (Drug)
结局指标
主要结局
Major bleeding
时间窗: 7 days
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Major adverse cardiac events
时间窗: 7 days
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
次要结局
- Major adverse cardiac events(180 days)
- Stent thrombosis ,TVR ,TLR(180 days)