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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate SR 300mg
Clopidogrel
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seung-Kee Min,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sarpogrelate SR 300mg + ASA

Clopidogrel + ASA

Arm Description

Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Anplone SR

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2016
Last Updated
July 26, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02959606
Brief Title
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study
Official Title
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarpogrelate SR 300mg + ASA
Arm Type
Experimental
Arm Description
Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Anplone SR
Arm Title
Clopidogrel + ASA
Arm Type
Active Comparator
Arm Description
Clopidogrel is administrated to patients with PAD for 6 weeks after EVT for femoro-popliteal regions. Other Name: Plavix
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate SR 300mg
Other Intervention Name(s)
Anplone SR
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Primary Outcome Measure Information:
Title
Restenosis rate (50%>) in 6 months by CT angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target lesion restenosis(TLR) in 6 months
Time Frame
6 months
Title
Major bleeding complication
Time Frame
6 months
Title
Ipsilateral major amputation
Time Frame
6 months
Title
All-cause mortality
Time Frame
6 months
Title
All adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Kee Min, MD.PhD.
Phone
+82.2-2072-0297
Email
skminmd@snuh.org
Facility Information:
Facility Name
Seung-Kee Min,
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Kee Min, MD.
Phone
+82.2-2072-0297
Email
skminmd@snuh.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
28938905
Citation
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.
Results Reference
derived

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

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