Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- major adverse cardiac and cerebral events at 1 year
研究概览
简要总结
Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).
In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ACS.
- •Between ages of 18 Years and 85 years.
- •Presence of one or several stenosis in native coronary arteries requiring PCI.
- •Willing and able to sign informed consent.
排除标准
- •A history of bleeding diathesis.
- •New York Heart Association functional class IV.
- •Prior PCI or coronary bypass grafting < 3 months.
- •Contraindications to statins, clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g/l; creatinine clearance <25 ml/ min; active liver disease).
- •Use of glycoprotein IIb/IIIa inhibitors before PCI.
- •Use of statins before PCI.
结局指标
主要结局
major adverse cardiac and cerebral events at 1 year
时间窗: 1 year
次要结局
- hemorrhage events and subacute thrombosis events at 1 year(1 year)