Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial

BACKGROUND: 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. METHODS: In the safety population, 12 254 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. RESULTS: 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, 0.85–1.44]; P =0.46). Major or CRNM bleeding occurred in 339 (5.5%) and 307 (5.0%), respectively (csHR, 1.12 [95% CI, 0.96–1.30]; P =0.16), and any bleeding in 763 (12.5%) and 752 (12.3%) (csHR, 1.02 [95% CI, 0.93–1.13]; P =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, 1.03–1.59]), and lower gastrointestinal bleeding in 102 (1.7%) and 59 (1.0%) (csHR, 1.75 [95% CI, 1.27–2.41]), primarily rectal bleeding. Any procedure-related bleeding and any mucosal bleeding did not differ significantly. CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT05686070.

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Journal
Circulation
Published
2026-10-13
DOI
https://doi.org/10.1161/circulationaha.126.081836
Primary Topic
Acute Ischemic Stroke Management
Type
article
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article

Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial

Vaidas Matijošaitis, Teruyuki Hirano, Jonathan M. Coutinho, Scott Eric Kasner et al.
Circulation
Acute Ischemic Stroke Management
article

Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial

Vaidas Matijošaitis, Teruyuki Hirano, Jonathan M. Coutinho, Scott Eric Kasner, Andrea Zini, Şerefnur Öztürk, Pablo F Amaya, Else Charlotte Sandset, Georgios K. Tsivgoulis, Jaime Masjuán, Pablo C. Colorado, Andrew M. Demchuk, Robin Lemmens, Hanne Christensen, Gisele Sampaio Silva, Yolanda Silva, Eva Muehlhofer, Óscar Ayo‐Martín, Roland C. Veltkamp, Ashkan Shoamanesh, Helle Klingenberg Iversen, Thompson Gordon Robinson, I‐Hui Lee, Mukul Sharma, Ashfaq M Shuaib, Туруспекова Сауле Тлеубергеновна, Michael Knoflach, José Manuel Ferro, Christoph Neumann, Jukka Putaala A, Raed A. Joundi, Agnieszka Słowik, Qiang Dong, Karleen M. Schulze, Robert Mikulík, Gian Marco De Marchis, Ronen R. Leker, Evija Miglāne, Hee‐Joon Bae, Dániel Bereczki, Bruce C.V. Campbell, Charlotte Cordonnier, Jeffrey L. Saver, Arne G. Lindgren, Padmavathy Narayanan Sylaja, Lars Keller, John W. Eikelboom, Martin Kovář, H. Bart van der Worp, Peter Turčáni, Lizhen Xu, Ziran Wang, Ivan Staikov, Fan Kee Hoo
article en

Abstract

BACKGROUND: 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. METHODS: In the safety population, 12 254 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. RESULTS: 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, 0.85–1.44]; P =0.46). Major or CRNM bleeding occurred in 339 (5.5%) and 307 (5.0%), respectively (csHR, 1.12 [95% CI, 0.96–1.30]; P =0.16), and any bleeding in 763 (12.5%) and 752 (12.3%) (csHR, 1.02 [95% CI, 0.93–1.13]; P =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, 1.03–1.59]), and lower gastrointestinal bleeding in 102 (1.7%) and 59 (1.0%) (csHR, 1.75 [95% CI, 1.27–2.41]), primarily rectal bleeding. Any procedure-related bleeding and any mucosal bleeding did not differ significantly. CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT05686070.

Circulation
Semmelweis University (HU), Jagiellonian University (PL), Oslo University Hospital (NO), Universiti Putra Malaysia (MY), Lithuanian University of Health Sciences (LT), The Royal Melbourne Hospital (AU), University of Helsinki (FI), Selçuk University (TR), Innsbruck Medical University (AT), National Yang Ming Chiao Tung University (TW), University of Leicester (GB), University of Alberta (CA), Inserm (FR), University of California, Los Angeles (US), University of Calgary (CA), Lund University (SE), Kyorin University (JP), Kazakh National Medical University (KZ), Hebrew University of Jerusalem (IL), National and Kapodistrian University of Athens (GR), Heidelberg University (DE), Université de Lille (FR), Florey Institute of Neuroscience and Mental Health (AU), Kantonsspital St. Gallen (CH), Hadassah Medical Center (IL), Tokuda Hospital (BG), Hospital Israelita Albert Einstein (BR), Sree Chitra Thirunal Institute for Medical Sciences and Technology (IN), Helsinki University Hospital (FI), Bispebjerg Hospital (DK), University Hospital Heidelberg (DE), Copenhagen University Hospital (DK), Rigshospitalet (DK), Population Health Research Institute (CA), Taipei Veterans General Hospital (TW), Seoul National University Bundang Hospital (KR), University of California System (US), University Medical Center Utrecht (NL), Centre Hospitalier Universitaire de Lille (FR), Linyi People's Hospital (CN), Fundación Valle del Lili (CO), Pauls Stradiņš Clinical University Hospital (LV), Na Homolce Hospital (CZ), Institut d'Investigació Biomèdica de Girona (ES), Istituto delle Scienze Neurologiche di Bologna (IT), Riga Stradiņš University (LV), St. Anne's University Hospital Brno (CZ), Skåne University Hospital (SE), University General Hospital Attikon (GR), Alfried Krupp Hospital (DE), Amsterdam University Medical Centers (NL), Hospital Universitari de Girona Doctor Josep Trueta (ES), Complejo Hospitalario Universitario de Albacete (ES), Huashan Hospital (CN), Hospital Universitario Ramón y Cajal (ES), Imperial College London (GB), Bayer (Germany) (DE), Comenius University Bratislava (SK), University of Pennsylvania (US), Universidade Federal de São Paulo (BR), Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
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Acute Ischemic Stroke Management
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