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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-01-31

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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sarpogrelate SR 300mg

Intervention Type DRUG

Clopidogrel + ASA

Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions.

Other Name: Plavix

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Interventions

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Sarpogrelate SR 300mg

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Other Intervention Names

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Anplone SR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No