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

July 26, 2017 updated by: Seung-Kee Min, Seoul National University Hospital

SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung-Kee Min, MD.PhD.
  • Phone Number: +82.2-2072-0297
  • Email: skminmd@snuh.org

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Sarpogrelate SR 300mg
Other Names:
  • 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
Drug: Clopidogrel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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