Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Platelet Reactivity
研究概览
简要总结
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
- •High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
- •Written Informed Consent
排除标准
- •History of bleeding diathesis
- •History of active bleeding within 6 months before randomization
- •Chronic oral anticoagulation treatment
- •Contraindications to antiplatelet treatment
- •Known platelet function disorders
- •Acute coronary syndrome within 30 days before randomization
- •Cardiogenic shock
- •Planned Percutaneous Coronary Intervention in the next 30 days
- •Haemodialysis
- •Platelet count < 100000/μL
- •Hematocrit < 30%
- •High likelihood of being unavailable on the Day 28 visit
- •History of stroke
- •Known allergy to clopidogrel and/or prasugrel
研究组 & 干预措施
Prasugrel
Prasugrel 10mg per day
干预措施: Prasugrel (Drug)
Clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change in Platelet Reactivity
时间窗: At 14 and 28 days after randomization
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization
次要结局
未报告次要终点
研究者
Dimitrios Alexopoulos
Professor
University of Patras