Peripheral Arterial Disease
Conditions
Brief 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.
Interventions
DRUGClopidogrel
DRUGSarpogrelate SR 300mg
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate (50%>) in 6 months by CT angiography | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactSeung-Kee Min, MD.PhD.
Outcome results
None listed