NCT00910299终止2 期
Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
研究概览
简要总结
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.
To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
- •Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
- •Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
- •VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.
排除标准
- •Non-ST segment elevation myocardial infarction within 14 days prior to randomization
- •ST-segment elevation myocardial infarction within 14 days prior to randomization
- •Have known major complications after percutaneous coronary intervention and prior to randomization
- •Have a body weight < 60 kilogram (kg)
- •Have cardiogenic shock at time of randomization
- •Have refractory ventricular arrhythmias
- •Have New York Heart Association Class IV congestive heart failure
- •Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
- •Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study
研究组 & 干预措施
Prasugrel
Experimental
干预措施: Prasugrel (Drug)
Clopidogrel
Active Comparator
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
时间窗: Baseline through 6 months
The endpoint in this measure is a combination of cardiovascular death or MI.
次要结局
- Number of Participants With Stent Thrombosis (ST)(Baseline through 6 months)
- Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)(Baseline through 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome SubjectsAcute Coronary SyndromeNCT00699998Eli Lilly and Company9,326
已完成
3 期
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic HemodialysisHemodialysisChronic Renal FailureNCT01155765University of Patras70
进行中（未招募）
不适用
Effectiveness of Prasugrel versus Clopidogrel in Subjects with High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention with Implantation of Drug-Eluting Stent - TACWReduction of composite cardio-vascular end-point in patients who have successfully undergone elective percutaneous coronary intervention with placement of at least one drug-eluting stent.EUCTR2008-004997-41-DEEli Lilly and Company3,250
已完成
4 期
Platelet Inhibition in Patients With Systolic Heart FailureSystolic Heart FailureNCT01765400University of Nebraska30
已完成
不适用
Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery DiseasePeripheral Artery DiseaseCoronary Artery DiseaseNCT01018940University of Oklahoma30