Comparison of clopidogrel-based antiplatelet therapy versus warfarin as a secondary prevention strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE): Rationale and design of a prospective, randomized, open-label, blinded-endpoint trial.
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Yang Wookjin, Park Hee-Kwon, Koh Seong-Ho, Kim Seongheon, Kim Yerim, Jung Keun-Hwa, Kang Hyun Goo, Choi Jay Chol, Kim Hahn Young, Nam Hyo Suk, Jeong Hye Seon, Kim Joon-Tae, Kim Young Seo, Yu Sungwook, Cho Kyung-Hee, Song Tae-Jin, Heo Sung Hyuk, Cho Han-Jin, Sohn Sung-Il, Chang Yoonkyung, Park Jong-Moo, Oh Mi-Sun, Kim Eung-Gyu, Shin Dong-Ick, Kim Chulho, Lee Jun, Ahn Seong Hwan, Lee Yeong-Bae, Shin Jong Wook, Kim Beom Joon, Kim Bum Joon, Park Kwang-Yeol, Kwon Hyung-Min, Jang Hyemin, Kim Jeong-Min, Kim Jinkwon, Lee Seung-Hoon, APS-STROKE investigators
Аннотация
METHODS: APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS and a history of ischemic stroke or transient ischemic attack (TIA) will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematosus, or other major indications for continued antiplatelet or anticoagulant therapy will be excluded. Participants will be randomized 1:1 to receive clopidogrel-based antiplatelet therapy or warfarin. More than 200 patients are planned for inclusion across 32 stroke centers. The primary endpoint is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during at least 4 years of follow-up. Secondary endpoints include major adverse cardiovascular events, ischemic stroke, any bleeding, major bleeding, intracranial bleeding, clinically relevant non-major bleeding, any death, and thrombosis-related death.
CONCLUSION: This study will provide valuable information on the optimal secondary prevention strategy for APS-related stroke.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT05995600; CRIS: KCT0008900.