NCT02959606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

November 8, 2016

Last Update Submit

July 26, 2017

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

Sarpogrelate SR 300mg + ASA

EXPERIMENTAL

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

Clopidogrel + ASA

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Sarpogrelate SR 300mgDRUG
Also known as: Anplone SR
Sarpogrelate SR 300mg + ASA
ClopidogrelDRUG
Clopidogrel + ASA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seung-Kee Min,

Seoul, 110-744, South Korea

RECRUITING

Related Publications (2)

  • Han A, Lee T, Lee J, Song SW, Lee SS, Jung IM, Kang JM, Gwon JG, Yun WS, Cho YP, Ko H, Park YJ, Min SK. A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention. Sci Rep. 2023 Feb 13;13(1):2502. doi: 10.1038/s41598-023-29006-z.

    PMID: 36781928DERIVED

  • Ahn S, Lee J, Min SK, Ha J, Min SI, Kim SY, Cho MJ, Cho S; SAFE study investigators. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials. 2017 Sep 22;18(1):439. doi: 10.1186/s13063-017-2155-5.

    PMID: 28938905DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

sarpogrelateClopidogrel

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Seung-Kee Min, MD.PhD.

CONTACT

+82.2-2072-0297skminmd@snuh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 9, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

KR(1)