TY - JOUR
T1 - Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention
AU - Sharma, Mukul
AU - Dong, Qiang
AU - Hirano, Teruyuki
AU - Kasner, Scott E
AU - Saver, Jeffrey
AU - Masjuan, Jaime
AU - Demchuk, Andrew M
AU - Cordonnier, Charlotte
AU - Bereczki, Daniel
AU - Tsivgoulis, Georgios
AU - Veltkamp, Roland
AU - Staikov, Ivan
AU - Bae, Hee-Joon
AU - Campbell, Bruce C V
AU - Zini, Andrea
AU - Lee, I-Hui
AU - Ameriso, Sebastian
AU - Kovar, Martin
AU - Mikulik, Robert
AU - Lemmens, Robin
AU - Ferro, José M
AU - Robinson, Thompson
AU - Christensen, Hanne
AU - Ozturk, Serefnur
AU - Leker, Ronen R
AU - Turcani, Peter
AU - Slowik, Agnieszka
AU - Amaya, Pablo
AU - Hoo, Fan Kee
AU - De Marchis, Gian Marco
AU - Knoflach, Michael
AU - Sylaja, Pillai N
AU - Putaala, Jukka
AU - Coutinho, Jonathan M
AU - Worp, H Bart van der
AU - Miglane, Evija
AU - Matijosaitis, Vaidas
AU - Lindgren, Arne G
AU - Silva, Gisele Sampaio
AU - Sandset, Else Charlotte
AU - Turuspekova, Saule Tleubergenovna
AU - Joundi, Raed A
AU - Schulze, Karleen
AU - Shestakovska, Olga
AU - Gilbride, Jennifer
AU - Bangdiwala, Shrikant I
AU - Xu, Lizhen
AU - Muehlhofer, Eva
AU - Colorado, Pablo
AU - Mundl, Hardi
N1 - Publisher Copyright:
© The Author(s) 2026. Published by Oxford University Press on behalf of the European Stroke Organisation.
PY - 2026/1
Y1 - 2026/1
N2 - INTRODUCTION: Genetic deficiency of factor XI is associated with a reduced risk of ischemic stroke. Asundexian is a direct inhibitor of activated factor XIa (FXIa) with a low risk of bleeding in early trials. We seek to determine its efficacy and safety combined with antiplatelet therapy for prevention of ischemic stroke.PATIENTS AND METHODS: Oral faCtor Eleven A iNhibitor asundexian as novel antithrombotiC (OCEANIC-STROKE) is a placebo-controlled, double-blind, event-driven randomised trial including participants with stroke (NIHSS ≤ 15) or high-risk TIA (ABCD2 6 or 7) within 72 h of onset. Participants had at least one of the following: atherosclerosis of extra- or intracranial vessels, a medical history of atherosclerosis or an imaged acute non-lacunar infarct. We excluded sources of stroke requiring anticoagulation and active non-trivial bleeding other than hemorrhagic infarction (HI 1 or 2). Participants received asundexian 50 mg daily or placebo stratified by planned concurrent antiplatelet therapy (single vs dual). The primary endpoint is time to ischemic stroke. We present baseline characteristics as of 5 June 2025.RESULTS: Between January 2023 and February 2025, we randomised 12,327 participants. Participants were 67% male with a mean (SD) age of 68 (11) years. Ischemic stroke was the index event for 95% of whom 27.4% had thrombolysis and/or mechanical thrombectomy. By TOAST classification, 43% of index strokes were LAA, 22% small vessel disease, 30% undetermined and 2% cardioembolic. Dual antiplatelets were planned in 63% as standard initial treatment. Trial completion is anticipated in October 2025.CONCLUSION: OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.TRIAL REGISTRATION: ClinicalTrials.gov (NCT05686070).
AB - INTRODUCTION: Genetic deficiency of factor XI is associated with a reduced risk of ischemic stroke. Asundexian is a direct inhibitor of activated factor XIa (FXIa) with a low risk of bleeding in early trials. We seek to determine its efficacy and safety combined with antiplatelet therapy for prevention of ischemic stroke.PATIENTS AND METHODS: Oral faCtor Eleven A iNhibitor asundexian as novel antithrombotiC (OCEANIC-STROKE) is a placebo-controlled, double-blind, event-driven randomised trial including participants with stroke (NIHSS ≤ 15) or high-risk TIA (ABCD2 6 or 7) within 72 h of onset. Participants had at least one of the following: atherosclerosis of extra- or intracranial vessels, a medical history of atherosclerosis or an imaged acute non-lacunar infarct. We excluded sources of stroke requiring anticoagulation and active non-trivial bleeding other than hemorrhagic infarction (HI 1 or 2). Participants received asundexian 50 mg daily or placebo stratified by planned concurrent antiplatelet therapy (single vs dual). The primary endpoint is time to ischemic stroke. We present baseline characteristics as of 5 June 2025.RESULTS: Between January 2023 and February 2025, we randomised 12,327 participants. Participants were 67% male with a mean (SD) age of 68 (11) years. Ischemic stroke was the index event for 95% of whom 27.4% had thrombolysis and/or mechanical thrombectomy. By TOAST classification, 43% of index strokes were LAA, 22% small vessel disease, 30% undetermined and 2% cardioembolic. Dual antiplatelets were planned in 63% as standard initial treatment. Trial completion is anticipated in October 2025.CONCLUSION: OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.TRIAL REGISTRATION: ClinicalTrials.gov (NCT05686070).
KW - Aged
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Ischemic Stroke/prevention & control
KW - Male
KW - Middle Aged
KW - Platelet Aggregation Inhibitors/therapeutic use
KW - Randomized Controlled Trials as Topic
KW - Secondary Prevention/methods
KW - Stroke/prevention & control
U2 - 10.1093/esj/aakaf017
DO - 10.1093/esj/aakaf017
M3 - Article
C2 - 41614533
SN - 2396-9873
VL - 11
JO - European Stroke Journal
JF - European Stroke Journal
IS - 1
M1 - aakaf017
ER -