Prasugrel in Comparison to High Clopidogrel Dose for Inhibition of Platelet Reactivity as Assessed With a Point-of-Care Platelet Function Assay in Patients Undergoing Chronic Hemodialysis Presenting Resistance to the Usual Clopidogrel Dose
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
Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a viable option. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Additionally, hemodialysis via the dialysis filter causes a decrease in glycoprotein platelet receptors, potentially associated with thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel 150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be carried out, without an interventing washout period. All patients will undergo platelet reactivity assessment, documentation of major adverse cardiac events and documentation of any serious adverse events(stroke, bleeding)at day 15 and day 30.
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
- •History of chronic renal failure under hemodialysis for at least 6 months
- •Under clopidogrel 75mg/day treatment for at least 7 days before randomization
- •Informed consent obtained in writing
排除标准
- •Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- •Breastfeeding
- •Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
- •Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization
- •Requirement for oral anticoagulant prior to the Day 30 visit
- •Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit
- •Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit
- •Known hypersensitivity to prasugrel or clopidogrel.
- •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 thienopyridine therapy.
- •Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- •Thrombocytopenia (<100.000 / μL) at randomization
- •Known liver failure (bilirubin > 2mg/dl)
研究组 & 干预措施
Prasugrel
Prasugrel per os 10 mg/day
干预措施: Prasugrel (Drug)
Clopidogrel
Clopidogrel per os 150 mg/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 30
次要结局
- Hemorrhage(Day 30)
- Major Adverse Cardiac Events (death, myocardial infarction, revascularization)(Day 30)
- Stroke(Day 30)