Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Major Adverse Limb Event Rates
研究概览
简要总结
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent before initiation of any study related procedures
- •Be at least 18 years of age
- •Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
- •At least 1 vessel run-off in segment distal to the intervention
- •Rutherford Classification 2-5 that is unresponsive to medical therapy
排除标准
- •Acute limb ischemia
- •Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
- •Patient undergoing atherectomy procedure
- •Intervention includes deployment of drug eluted stent
- •Critical limb ischemia (Rutherford Classification 6)
- •Thrombocytopenia: Platelet count <50k
- •Liver disease (Childs-Pugh B or C)
- •Existing need for on going clopidogrel therapy
- •Proton Pump Inhibitor Use (If unable to be switched)
- •Need for therapeutic anticoagulation
- •Known hypercoagulable disorder
- •Allergy or contraindication to aspirin or clopidogrel
- •Patients enrolled in another investigational drug or device study within the past 30 days
研究组 & 干预措施
Short Term
The short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only.
干预措施: Aspirin (Drug)
Short Term
The short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only.
干预措施: Clopidogrel (Drug)
Long Term
The long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only.
干预措施: Aspirin (Drug)
Long Term
The long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Major Adverse Limb Event Rates
时间窗: 12 months post-intervention
Severe limb ischemia leading to a reintervention or major vascular amputation
Major Adverse Cardiovascular Event Rates
时间窗: 12 months post-intervention
Stroke, Myocardial Infarction, Cardiovascular Death
次要结局
- Quality of Life Outcome(12 Months post-intervention)
研究者
Vikram S. Kashyap, M.D.
Chief, Division of Vascular Surgery & Endovascular Therapy
University Hospitals Cleveland Medical Center