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

Phase 4

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Sarpogrelate SR 300mg; Drug: Clopidogrel

• Registration Number: NCT02959606
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Study Start: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-27
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarpogrelate SR 300mg + ASA	Sarpogrelate SR 300mg	Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Anplone SR
Clopidogrel + ASA	Clopidogrel	Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Plavix

Primary Outcome Measures

Name	Time	Method
Restenosis rate (50%>) in 6 months by CT angiography	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seung-Kee Min,; 🇰🇷 Seoul, Korea, Republic of