SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Restenosis rate (50%>) in 6 months by CT angiography
研究概览
简要总结
After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent EVT for femoro-popliteal occlusive disease.
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
- •Adult, >18 years old
- •Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis
- •Successful FP intervention; residual stenosis <30%
- •Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)
- •patent outflow status; at least 1 arterial runoff in below knee arteries
- •All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A~ D
排除标准
- •At risk of hemorrhage, bleeding tendency or thrombophilia
- •Acute limb ischemia / inflammatory arterial disease
- •Contraindication or allergic to ASA, clopidogrel, Anplone
- •Medication of warfarin
- •Pregnancy, hepatic dysfunction, thrombocytopenia
- •Previous FP bypass or intervention
- •Impossible to stop clopidogrel before EVT
研究组 & 干预措施
Clopidogrel + ASA
Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.
Other Name: Plavix
干预措施: Clopidogrel (Drug)
Sarpogrelate SR 300mg + ASA
Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.
Other Name: Anplone SR
干预措施: Sarpogrelate SR 300mg (Drug)
结局指标
主要结局
Restenosis rate (50%>) in 6 months by CT angiography
时间窗: 6 months
次要结局
- Target lesion restenosis(TLR) in 6 months(6 months)
- Major bleeding complication(6 months)
- Ipsilateral major amputation(6 months)
- All-cause mortality(6 months)
- All adverse events(6 months)
研究者
Seung-Kee Min
Professor
Seoul National University Hospital