Evidence map›Paper›PMID 28938905›Full record

Trial reportTrials2017

SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial.

Sanghyun Ahn, Joongyub Lee, Seung-Kee Min, Jongwon Ha, Sang-Il Min, Song-Yi Kim, Min-Ji Cho, Sungsin Cho, SAFE study investigators

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02959606 (SAFE), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact, top 79% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02959606 phase4unknown statusnot on this map

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

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2019Enrolled272ConditionsPeripheral Arterial DiseaseArmsSarpogrelate SR 300mg, Clopidogrel
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Sanghyun AhnDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Joongyub LeeDivision of Clinical Epidemiology, Medical Research Collaborating Center, Biomedical Research Institution, Seoul National University Hospital, Seoul, South Korea.
Seung-Kee MinDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. docmin88@snu.ac.kr.
Jongwon HaDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Sang-Il MinDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Song-Yi KimDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Min-Ji ChoDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
Sungsin ChoDepartment of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.
SAFE study investigators
Seoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSarpogrelate is expected to reduce restenosis by protecting blood vessels from oxidative stress and vascular endothelial dysfunction as well as by acting as an antiplatelet agent after endovascular treatment (EVT). This trial was designed to compare aspirin plus sustained-release (SR) sarpogrelate with aspirin plus clopidogrel for the prevention of restenosis in patients with femoro-popliteal (FP) peripheral artery disease (PAD) who underwent EVT. METHODS/

designThis is an open label, multicenter, prospective randomized controlled clinical trial. Patients will be eligible for inclusion in this study if they require EVT for stenosis or occlusion of a de novo FP lesion. Patients in each group will receive aspirin 100 mg with clopidogrel 75 mg or aspirin 100 mg with SR sarpogrelate 300 mg (Anplone®) orally once a day for six months. The primary outcome of the study is the restenosis rate, defined as > 50% luminal reduction by computed tomography angiography or catheter angiography in the six-month follow-up period. Secondary outcomes include target lesion revascularization, major bleeding, ipsilateral major amputation, all-cause mortality, and all adverse events that take place in those six months. DISCUSSION: This study is a multicenter randomized controlled trial designed to show non-inferiority in terms of the re-stenosis rate of SR sarpogrelate compared to clopidogrel for EVT for PAD in FP lesion patients.

trial registrationClinicalTrials.gov, NCT02959606 . Registered on 9 November 2016.

Indexed as

Endovascular ProceduresAmputation, SurgicalAspirinClinical ProtocolsClopidogrelComputed Tomography AngiographyConstriction, PathologicDrug Therapy, CombinationFemoral ArteryHemorrhageHumansLimb SalvagePeripheral Arterial DiseasePlatelet Aggregation InhibitorsPopliteal ArteryProspective StudiesAspirinClopidogrelPlatelet Aggregation InhibitorssarpogrelateSuccinatesTiclopidineEndovascular treatmentFemoro-poplitealPeripheral artery diseaseSarpogrelateStenosis

Identifiers

PMID28938905
PMCPMC5610452
OpenAlexW2759909757

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.