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

Overview

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.

Full Title of Study: “SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2019

Interventions

  • Drug: Sarpogrelate SR 300mg
  • Drug: Clopidogrel

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: Clopidogrel + ASA
    • Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Plavix

Clinical Trial Outcome Measures

Primary Measures

  • Restenosis rate (50%>) in 6 months by CT angiography
    • Time Frame: 6 months

Secondary Measures

  • Target lesion restenosis(TLR) in 6 months
    • Time Frame: 6 months
  • Major bleeding complication
    • Time Frame: 6 months
  • Ipsilateral major amputation
    • Time Frame: 6 months
  • All-cause mortality
    • Time Frame: 6 months
  • All adverse events
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Seung-Kee Min, Professor – Seoul National University Hospital
  • Overall Contact(s)
    • Seung-Kee Min, MD.PhD., +82.2-2072-0297, skminmd@snuh.org

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