Clinical Impact of High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures. The PRECLOP Study (Platelet REsponsiveness to CLOpidogrel Treatment After Peripheral Angioplasty or Stenting)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major event-free survival
研究概览
简要总结
Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.
- •Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure.
排除标准
- •Acute limb ischemia
- •Coagulation disorders
- •Known allergy to clopidogrel
- •Failure to comply with the antiplatelet treatment protocol
- •Aortoiliac disease
结局指标
主要结局
Major event-free survival
时间窗: 12 months
12 months freedom from all causes of death, stroke, index limb amputation, non pre-scheduled minor amputation, index limb bypass surgery and target vessel recanalization (TVR)stratified according to PRU values distribution
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
时间窗: 12 months
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition measured with VerifyNow P2Y12 assay point-of-care testing, influencing the 12 months primary outcome of major event-free survival estimated by ROC analysis
次要结局
- Positive and negative predictive value of PRU testing(12 months)
- Bleeding rate(12 months)
研究者
SIABLIS DIMITRIOS
Dimitrios Siablis, Professor of Radiology
University of Patras