{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T20:49:31Z","timestamp":1791924571618,"version":"4.3.4"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T00:00:00Z","timestamp":1767312000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and methods<\/jats:title>\n                    <jats:p>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 \u2264\u200915) or high-risk TIA (ABCD2 6 or 7) within 72\u00a0h 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\u00a0mg 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (NCT05686070).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/esj\/aakaf017","type":"journal-article","created":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T11:02:36Z","timestamp":1768906956000},"source":"Crossref","is-referenced-by-count":6,"title":["Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention"],"prefix":"10.1093","volume":"11","author":[{"given":"Mukul","family":"Sharma","sequence":"first","affiliation":[{"name":"Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada"},{"name":"McMaster University, Department of Medicine, McMaster University, Hamilton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiang","family":"Dong","sequence":"additional","affiliation":[{"name":"Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teruyuki","family":"Hirano","sequence":"additional","affiliation":[{"name":"Department of Stroke and Cerebrovascular Medicine, Kyorin University, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott E","family":"Kasner","sequence":"additional","affiliation":[{"name":"Department of Neurology Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Saver","sequence":"additional","affiliation":[{"name":"Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime","family":"Masjuan","sequence":"additional","affiliation":[{"name":"Neurology Department, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M","family":"Demchuk","sequence":"additional","affiliation":[{"name":"Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Cordonnier","sequence":"additional","affiliation":[{"name":"Department of Neurology and Stroke Center, Lille University Hospital Center, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Bereczki","sequence":"additional","affiliation":[{"name":"Department of Neurology, Semmelweis University, Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgios","family":"Tsivgoulis","sequence":"additional","affiliation":[{"name":"Second Department of Neurology, National & Kapodistrian University of Athens, School of Medicine, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland","family":"Veltkamp","sequence":"additional","affiliation":[{"name":"Department of Neurology and Epileptology, Alfried Krupp Krankenhaus, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Staikov","sequence":"additional","affiliation":[{"name":"Department of Neurology and Sleep Medicine, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hee-Joon","family":"Bae","sequence":"additional","affiliation":[{"name":"Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce C V","family":"Campbell","sequence":"additional","affiliation":[{"name":"Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melborne , Parkville, Victoria ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Zini","sequence":"additional","affiliation":[{"name":"Department of Neurology and Stroke Center, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna, AUSL Bologna, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I-Hui","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of 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