{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T09:46:16Z","timestamp":1791884776579,"version":"4.3.4"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"abstract":"\n BACKGROUND:<\/jats:title>\n OCEANIC-STROKE (XXX) showed that asundexian added to antiplatelet therapy reduced ischemic stroke without significantly increasing bleeding in patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack. We characterized bleeding categories, sites, and key subgroups.<\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n In the safety population, 12\u2009254 participants received at least 1 dose of asundexian (n=6124) or placebo (n=6130). Bleeding was categorized by International Society on Thrombosis and Haemostasis criteria as major, clinically relevant nonmajor (CRNM), or minor. While-on-treatment analyses included events through 2 days after the last dose, with death and permanent discontinuation as competing risks.<\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n \n Major bleeding occurred in 117 (1.9%) participants with asundexian and 107 (1.7%) with placebo (cause-specific hazard ratio [csHR], 1.10 [95% CI, 0.85\u20131.44];\n P<\/jats:italic>\n =0.46). Major or CRNM bleeding occurred in 339 (5.5%) and 307 (5.0%), respectively (csHR, 1.12 [95% CI, 0.96\u20131.30];\n P<\/jats:italic>\n =0.16), and any bleeding in 763 (12.5%) and 752 (12.3%) (csHR, 1.02 [95% CI, 0.93\u20131.13];\n P<\/jats:italic>\n =0.65). Treatment effects for major and major or CRNM bleeding were consistent across prespecified subgroups, including planned dual antiplatelet therapy. Symptomatic intracranial hemorrhage occurred in 41 (0.7%) and 36 (0.6%) participants. Any gastrointestinal bleeding occurred in 186 (3.0%) and 147 (2.4%) (csHR, 1.28 [95% CI, 1.03\u20131.59]), and lower gastrointestinal bleeding in 102 (1.7%) and 59 (1.0%) (csHR, 1.75 [95% CI, 1.27\u20132.41]), primarily rectal bleeding. Any procedure-related bleeding and any mucosal bleeding did not differ significantly.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n Asundexian added to antiplatelet therapy reduced ischemic stroke without significantly increasing major, major or CRNM, or any bleeding. Lower gastrointestinal bleeding was more frequent with asundexian, whereas treatment effects on major and major or CRNM bleeding were consistent across prespecified subgroups.<\/jats:p>\n <\/jats:sec>\n \n REGISTRATION:<\/jats:title>\n \n URL:\n https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n ; Unique Identifier: NCT05686070.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/circulationaha.126.081836","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T09:00:21Z","timestamp":1791882021000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial"],"prefix":"10.1161","clinical-trial-number":[{"clinical-trial-number":"nct05686070","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4126-1285","authenticated-orcid":true,"given":"John W.","family":"Eikelboom","sequence":"first","affiliation":[{"name":"Population Health Research Institute, Hamilton Health Sciences, McMaster University, Canada (J.W.E., L.X., A. Shoamanesh, K.S., R.A.J., M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lizhen","family":"Xu","sequence":"additional","affiliation":[{"name":"Population Health Research Institute, Hamilton Health Sciences, McMaster University, Canada (J.W.E., L.X., A. Shoamanesh, K.S., R.A.J., M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2802-1626","authenticated-orcid":true,"given":"Ashkan","family":"Shoamanesh","sequence":"additional","affiliation":[{"name":"Population Health Research Institute, Hamilton Health Sciences, McMaster University, Canada (J.W.E., L.X., A. Shoamanesh, K.S., R.A.J., M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3874-0130","authenticated-orcid":true,"given":"Qiang","family":"Dong","sequence":"additional","affiliation":[{"name":"Huashan Hospital Fudan University, Shanghai, China (Q.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2094-2428","authenticated-orcid":true,"given":"Teruyuki","family":"Hirano","sequence":"additional","affiliation":[{"name":"Department of Stroke and Cerebrovascular Medicine, Kyorin University School of Medicine, Shinkawa, Japan (T.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9141-2251","authenticated-orcid":true,"given":"Jeffrey L.","family":"Saver","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine, University of California\u2013Los Angeles (J.L.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1329-0943","authenticated-orcid":true,"given":"Jaime","family":"Masjuan","sequence":"additional","affiliation":[{"name":"Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain (J.M.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4930-7789","authenticated-orcid":true,"given":"Andrew M.","family":"Demchuk","sequence":"additional","affiliation":[{"name":"University of Calgary, Canada (A.M.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5697-6892","authenticated-orcid":true,"given":"Charlotte","family":"Cordonnier","sequence":"additional","affiliation":[{"name":"University of Lille, Inserm, CHU Lille, France (C.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8374-0500","authenticated-orcid":true,"given":"Daniel","family":"Bereczki","sequence":"additional","affiliation":[{"name":"Semmelweis University, Budapest, Hungary (D.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0640-3797","authenticated-orcid":true,"given":"Georgios","family":"Tsivgoulis","sequence":"additional","affiliation":[{"name":"Second Department of Neurology, National and Kapodistrian University of Athens, School of Medicine, \u201cAttikon\u201d University Hospital, Athens, Greece (G.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0583-1300","authenticated-orcid":true,"given":"Roland","family":"Veltkamp","sequence":"additional","affiliation":[{"name":"Department of Neurology, Alfried Krupp Krankenhaus Essen, Germany (R.V.)."},{"name":"Department of Brain Sciences, Imperial College London, United Kingdom (R.V.)."},{"name":"Department of Neurology, University Hospital Heidelberg, Germany (R.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Staikov","sequence":"additional","affiliation":[{"name":"Department of Neurology, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria (I.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0051-1997","authenticated-orcid":true,"given":"Hee-Joon","family":"Bae","sequence":"additional","affiliation":[{"name":"Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea (H.-J.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3632-9433","authenticated-orcid":true,"given":"Bruce C.V.","family":"Campbell","sequence":"additional","affiliation":[{"name":"Department of Medicine and Neurology, Melbourne Brain Centre at Royal Melbourne Hospital, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia (B.C.V.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1486-4507","authenticated-orcid":true,"given":"Andrea","family":"Zini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5344-6685","authenticated-orcid":true,"given":"I-Hui","family":"Lee","sequence":"additional","affiliation":[{"name":"Taipei Veterans General Hospital, Taipei City, Taiwan (I-H.L.)."},{"name":"National Yang Ming Chiao Tung University, Taipei City, Taiwan (I-H.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5488-8354","authenticated-orcid":true,"given":"Martin","family":"Kov\u00e1\u0159","sequence":"additional","affiliation":[{"name":"Na Homolce Hospital, Prague, Czechia (M. 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