SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Clopidogrel; Sarpogrelate

Criteria

Inclusion Criteria:

1. Adult, >18 years old

2. Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis

3. Successful FP intervention; residual stenosis <30%

4. Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)

5. patent outflow status; at least 1 arterial runoff in below knee arteries

6. All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A~ D

Exclusion Criteria:

1. At risk of hemorrhage, bleeding tendency or thrombophilia

2. Acute limb ischemia / inflammatory arterial disease

3. Contraindication or allergic to ASA, clopidogrel, Anplone

4. Medication of warfarin

5. Pregnancy, hepatic dysfunction, thrombocytopenia

6. Previous FP bypass or intervention

7. Impossible to stop clopidogrel before EVT