Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
研究概览
简要总结
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •Age ≥18 years old
- •Patients having PCI with stenting 24-48 hours prior randomization, for
- •Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
- •Written Informed consent
- •Platelet reactivity units (PRU) (VerifyNow) >230
排除标准
- •A history of bleeding diathesis
- •Chronic oral anticoagulation treatment
- •Contraindications to antiplatelet therapy
- •Known platelet function disorders
- •PCI or coronary artery bypass surgery < 3 months
- •Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
- •Planned staged PCI in the next 60 days
- •Hemodynamic instability
- •Cancer or hemodialysis
- •Platelet count <100 000/ μL, hematocrit <30%
- •Creatinine clearance <25 ml/min
- •A life expectancy<1 year, inability to give informed consent
- •High likelihood of being unavailable for the Day 60 follow up
研究组 & 干预措施
prasugrel
prasugrel per os 10mg/day
干预措施: prasugrel (Drug)
clopidogrel
clopidogrel per os 150mg/day
干预措施: clopidogrel (Drug)
结局指标
主要结局
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
时间窗: Day 60
次要结局
未报告次要终点