drugset / Trial / NCT02959606
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-12
- Primary completion
- 2019-01
- Completion
- 2019-01
Publications
- Han A, Lee T, Lee J, Song SW, Lee SS, Jung IM, Kang JM, Gwon JG, Yun WS, Cho YP, Ko H, Park YJ, Min SK. A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention. Sci Rep. 2023 Feb 13;13(1):2502. doi: 10.1038/s41598-023-29006-z.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clopidogrel | Small molecule | 75 mg | — |
| Subject | Sarpogrelate | Small molecule | 300 mg | Oral |