SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 121Â kb

Jongwon Ha

Joongyub Lee

Min-Ji Cho

SAFE study investigators

Sang-il Min

Sanghyun Ahn

Seung-Kee Min

Song-Yi Kim

Sungsin Cho

Trials

Sanghyun Ahn (4221169)

Joongyub Lee (504592)

Seung-Kee Min (2938875)

Jongwon Ha (230912)

Sang-il Min (2938872)

Song-Yi Kim (4456264)

Min-Ji Cho (4456270)

Sungsin Cho (4456267)

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Additional file 1: of SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial

Abbreviations
ABI: Ankle–brachial index; CTA: Computed tomography angiography; CVD: Cardiovascular disease; DAPT: Dual antiplatelet therapy; EVT: Endovascular treatment; FP: Femoro-popliteal; PAD: Peripheral artery disease; PCI: Percutaneous coronary intervention; TASC: Transatlantic InterSociety ConsensusAbstract
              
                Background
                Sarpogrelate 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/Design
                This 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 100mg with clopidogrel 75mg or aspirin 100mg with SR sarpogrelate 300mg (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.This is an investigator-sponsored study supported by a grant from Daewoong Pharmaceutical Company, Korea

Ahn, Sanghyun

Lee, Joongyub

Min, Seung-Kee

Ha, Jongwon

Min, Sang-il

Kim, Song-Yi

Cho, Min-Ji

Cho, Sungsin

SNU Open Repository and Archive

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

Abstract Background Sarpogrelate 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/Design This 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 registration ClinicalTrials.gov, NCT02959606 . Registered on 9 November 2016

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Additional file 1: of SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial

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