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

Study Overview
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Brief Summary
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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.

Official Title
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SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Sarpogrelate SR 300mg
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarpogrelate SR 300mg + ASA<br>Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Anplone SR | Drug: Sarpogrelate SR 300mg<br> <br> * Other names: Anplone SR;|
| Active Comparator: Clopidogrel + ASA<br>Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Plavix | Drug: Clopidogrel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate (50%>) in 6 months by CT angiography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |