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

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.

Keywords: Endovascular treatment; Femoro-popliteal; Peripheral artery disease; Sarpogrelate; Stenosis.

Conflict of interest statement

Ethics approval and consent to participate

This study follows the principles of the Helsinki Declaration and all patients will provide written informed consent prior to participation. Participation can be withdrawn at any time without any negative consequences concerning current or future medical treatment. Study approval was given by the Institutional Review Board of Seoul National University Hospital (IRB No. 1607-151-778). Any amendment will be submitted to the Local Ethics Committee.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig 1
Fig 1
Flow diagram of SAFE study. EVT endovascular treatment, ASA aspirin, R randomization
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure (Additional file 1)

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