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

John W. Eikelboom, Lizhen Xu, Ashkan Shoamanesh, Qiang Dong, Teruyuki Hirano, Jeffrey L. Saver, Jaime Masjuán, Andrew M. Demchuk, Charlotte Cordonnier, Dániel Bereczki

Ещё 44 автора

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

2026

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DOI 10.1161/circulationaha.126.081836

Достоверность данных 70 средняя

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Аннотация

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.