Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention

Sharma M. Dong Q. Hirano T. Kasner S.E. Saver J. Masjuan J. Demchuk A.M. Cordonnier C. Bereczki D. Tsivgoulis G. Veltkamp R. Staikov I. Bae H.-J. Campbell B.C.V. Zini A. Lee I.-H. Ameriso S. Kovar M. Mikulik R. Lemmens R. Ferro J.M. Robinson T. Christensen H. Ozturk S. Leker R.R. Turcani P. Slowik A. Amaya P. Hoo F.K. De Marchis G.M. Knoflach M. Sylaja P.N. Putaala J. Coutinho J.M. Worp H.B.V. Miglane E. Matijosaitis V. Lindgren A.G. Silva G.S. Sandset E.C. Turuspekova S.T. Joundi R.A. Schulze K. Shestakovska O. Gilbride J. Bangdiwala S.I. Xu L. Muehlhofer E. Colorado P. Mundl H. Keller L. Shoamanesh A.
1 January 2026

European stroke journal
2026 #11 Issue 1

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).

asundexian , factor XI , prevention , randomised trial , stroke

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Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada
Department of Medicine, McMaster University, Hamilton, Canada
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
Department of Stroke and Cerebrovascular Medicine, Kyorin University, Tokyo, Japan
Department of Neurology Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States
Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, United States
Neurology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain
Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada
Department of Neurology and Stroke Center, Lille University Hospital Center, Lille, France
Department of Neurology, Semmelweis University, Budapest, Hungary
Second Department of Neurology, National & Kapodistrian University of Athens, School of Medicine, Athens, Greece
Department of Neurology and Epileptology, Alfried Krupp Krankenhaus, Essen, Germany
Department of Neurology and Sleep Medicine, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria
Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melborne, Parkville, VIC, Australia
Department of Neurology and Stroke Center, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna, AUSL Bologna, Bologna, Italy
Department of Neurology, Taipei Veterans General Hospital, Taipei City, Taiwan
Section of Vascular Neurology, Institute for Neurological Research - FLENI, Buenos Aires, Argentina
Department of Neurology, Nemocnice Na Homolce, Czechia, Prague, United States
International Clinical Research Center, St. Anns University Hospital, Czechia, Brno
Department of Neurosciences, Experimental Neurology, KU Leuven, Leuven, Belgium
Department of Neurology, University Hospitals Leuven, Leuven, Belgium
Department of Neurology, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal
Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom
Department of Clinical Medicine, Copenhagen University Hospital, Copenhagen, Denmark
Department of Neurology, Selcuk University, Konya, Turkey
Department of Neurology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
1st Department of Neurology, Comenius University, Bratislava, Slovakia
Clinical Department of Neurology, Szpital Uniwersytecki w Krakowie, Krakow, Poland
Neurology Department, Fundacion Valle del Lili University Hospital, Cali, Columbia
Department of Neurology, Universiti Putra Malaysia, Selangor, Malaysia
Department of Neurology, University Research and Teaching Hospital, HOCH-Kantonssspital St. Gallen, St. Gallen, Switzerland
Department of Neurology, Medical University Innsbruck, Innsbruck, Austria
Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India
Neurocenter, Helsinki University Hospital, Helsinki, Finland
Department of Neurology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands
Department of Neurology and Neurosurgery, P. Stradins Clinical University Hospital, Riga, Latvia
Riga Stradins University, Department of Neurology and Neurosurgery, Riga, Latvia
Department of Neurology, Lithuanian University of Health Sciences, Kaunas, Lithuania
Department of Neurology, Skåne University Hospital, Lund, Sweden
Department of Clinical Sciences Lund, Neurology, Lund University, Lund, Sweden
Department of Neurology, Universidade Federal de São Paulo-UNIFESP and Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Department of Neurology, Oslo University Hospital, Oslo, Norway
Department of Nervous Diseases, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan
Bayer AG, Wuppertal, Germany

Population Health Research Institute
Department of Medicine
Department of Neurology
Department of Stroke and Cerebrovascular Medicine
Department of Neurology Perelman School of Medicine
Department of Neurology and Comprehensive Stroke Center
Neurology Department
Departments of Clinical Neurosciences and Radiology
Department of Neurology and Stroke Center
Department of Neurology
Second Department of Neurology
Department of Neurology and Epileptology
Department of Neurology and Sleep Medicine
Department of Neurology
Department of Medicine and Neurology
Department of Neurology and Stroke Center
Department of Neurology
Section of Vascular Neurology
Department of Neurology
International Clinical Research Center
Department of Neurosciences
Department of Neurology
Department of Neurology
Department of Cardiovascular Sciences
Department of Clinical Medicine
Department of Neurology
Department of Neurology
1st Department of Neurology
Clinical Department of Neurology
Neurology Department
Department of Neurology
Department of Neurology
Department of Neurology
Department of Neurology
Neurocenter
Department of Neurology
Department of Neurology and Neurosurgery
Department of Neurology and Neurosurgery
Riga Stradins University
Department of Neurology
Department of Neurology
Department of Clinical Sciences Lund
Department of Neurology
Department of Neurology
Department of Nervous Diseases
Bayer AG

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