Asundexian Cuts Recurrent Ischemic Stroke Without Excess Bleeding

OCEANIC-STROKE demonstrates that adding the oral factor XIa inhibitor asundexian to antiplatelet therapy reduces recurrent noncardioembolic ischemic stroke without increasing major bleeding, validating factor XIa as a therapeutic target for secondary prevention.

asundexianfactor XIa inhibitorfactor XIsecondary stroke preventionischemic strokeTIAantiplatelet therapyanticoagulationOCEANIC-STROKEphase 3 RCTBayer Cardiology / Anticoagulation

Background Information

Could a new anticoagulant improve stroke prevention?

Secondary prevention of ischemic stroke is crucial to reduce recurrent events and improve patient outcomes. Asundexian, an oral factor XIa inhibitor, was tested for effectiveness in combination with antiplatelet therapy versus antiplatelet therapy alone for preventing recurrent ischemic stroke. This phase 3 study explores a novel anticoagulant approach for secondary stroke prevention, which may enhance treatment strategies if shown effective. However, detailed results are needed to evaluate its clinical impact. Asundexian could be a promising option for enhancing secondary prevention in ischemic stroke patients.

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Authors: Sharma M, Dong Q, Hirano T, Kasner SE, Saver JL, Masjuan J, Demchuk AM, Cordonnier C, Bereczki D, Tsivgoulis G, Veltkamp R, Staikov I, Bae HJ, Campbell BCV, Zini A, Lee IH, Kovar M, Mikulik R, Lemmens R, Ferro JM, Robinson T, Christensen H, Ozturk S, Leker RR, Turcani P, Slowik A, Amaya P, Hoo FK, De Marchis GM, Knoflach M, Sylaja PN, Putaala J, Coutinho JM, van der Worp HB, Miglane E, Matijošaitis V, Lindgren AG, Sampaio Silva G, Sandset EC, Turuspekova ST, Amarenco P, Sheth KN, Smith EE, Eikelboom JW, Joundi RA, Schulze K, Xu L, Heenan L, Colorado P, Keller L, Muehlhofer E, Neumann C, Mundl H, Shoamanesh A, OCEANIC-STROKE Investigators

Citation: Sharma M, Dong Q, Hirano T, et al. Asundexian for Secondary Stroke Prevention. The New England journal of medicine. 2026;394(15):1467-1479. doi:10.1056/NEJMoa2513880

Article Links: PubMed · Journal / DOI

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Executive Summary

Study Design

Patient Population

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Secondary Outcomes & Safety Profile

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Clinical Pearls

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