The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during PCI or not.
详细描述
Ticagrelor is a new drug compared with clopidogrel. It has a stronger antiplatelet capacity. After PCI，whether using low molecular weight heparin can make patients better prognosis or not, What's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years ;
- •unstable angina, non-ST segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia;
- •voluntary participation in clinical trials, and informed consent;
排除标准
- •acute ST segment elevation myocardial infarction, stable angina pectoris;
- •aspirin allergy or resistance;
- •consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications;
- •patients have coagulopathy;
- •can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor;
- •can not complete revascularization;
- •NYHA ≥Ⅲ level or left ventricular ejection fraction <40%;
- •severe liver and kidney dysfunction (ALT and AST were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);
研究组 & 干预措施
full amount low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital.
干预措施: Ticagrelor (Drug)
full amount low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with full amount low molecular weight heparin until they leave hospital.
干预措施: full amount low molecular weight heparin (Drug)
half amount low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital.
干预措施: Ticagrelor (Drug)
half amount low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with half amount low molecular weight heparin until they leave hospital.
干预措施: half amount low molecular weight heparin (Drug)
No low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.
干预措施: Ticagrelor (Drug)
No low molecular weight heparin
Patients were treated with ticagrelor one year，After PCI， the patients are treated with no low molecular weight heparin.
干预措施: No low molecular weight heparin (Drug)
结局指标
主要结局
all cause mortality
时间窗: one year
次要结局
- Nonfatal myocardial infarction(one year)
- Bleeding events(one year)
- Non-fatal stroke(one year)
- Revascularization again(one year)
- Rehospitalization for ACS or heart failure(one year)
研究者
Zhao Jing Ye
Principal Investigator
Beijing Anzhen Hospital