Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Platelet reactivity
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. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.
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 95 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 hours prior randomization, meeting the following criteria :
- •Acute coronary syndrome (unstable angina or myocardial infarction)
- •TIMI risk score>2
- •Platelet reactivity in PRU ≥235 24 hours post-PCI
- •Age≥75 years and/or weight<60 Kg
- •Informed consent obtained in writing
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 30 days
- •Hemodynamic instability
- •hemodialysis
- •Creatinine clearance <25 ml/min
- •inability to give informed consent
- •High likelihood of being unavailable for the Day 30
- •History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- •Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
- •Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- •Thrombocytopenia (<100.000 / μL) at randomization
- •Anaemia (Hct <30%) at randomization
- •Polycythaemia (Hct > 52%) at randomization
- •Periprocedural IIb/IIIa inhibitor administration
研究组 & 干预措施
Clopidogrel
Clopidogrel 150mg per day for 15 days
干预措施: Clopidogrel (Drug)
Prasugrel
Prasugrel 5mg for 15 days
干预措施: Prasugrel (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: 15 days
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period
次要结局
- Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods(15 days)
研究者
Dimitrios Alexopoulos
Professor
University of Patras