Effects of Prolonged Dual Antiplatelet Therapy With Clopidogrel Plus Acetylsalicylic Acid (ASA) After Percutaneous Lower Extremity Revascularization in Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
研究概览
简要总结
The objective of the present study was to evaluate the prognostic impact of prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of major adverse cardiovascular events and major adverse limb events after percutaneous lower extremity revascularization in patients with lower extremity peripheral arterial disease (LE-PAD).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LE-PAD at stage 2 of Fontaine's classification (intermittent claudication)
- •successful PTA of aorto-iliac, femoro-popliteal ore below-the-knee segments
排除标准
- •critical limb ischemia
- •recent acute coronary syndrome (< 12 months)
- •recent cerebrovascular event (< 12 months)
- •recent myocardial, carotid or peripheral revascularization (< 12 months)
- •recent history of bleeding (< 12 months)
- •other indication for clopidogrel therapy
- •indication for anticoagulation
- •de-compensated heart failure
- •malignant neoplasm
研究组 & 干预措施
Short DAPT
Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
干预措施: Short DAPT (Drug)
Long DAPT
Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
干预措施: Long DAPT (Drug)
结局指标
主要结局
Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events
时间窗: 24 months post-PTA
Impact of prolonged vs. short dual antiplatelet therapy after PTA on the incidence of major adverse cardiovascular events (death from cardiovascular cause, myocardial infarction, stroke, coronary or carotid revascularization) + the incidence of major adverse limb events (restenosis, occlusion, or new revascularization of target lesion, new stenosis, occlusion, or revascularization of not-target lesion, onset of acute and critical limb ischemia, amputation).
次要结局
- Incidence of minor and major bleedings according to the GUSTO classification(24 months post-PTA)
研究者
Giuseppe Giugliano
MD, PhD
Federico II University