Asundexian for Secondary Stroke Prevention

BACKGROUND: Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear. METHODS: In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding. RESULTS: Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively. CONCLUSIONS: Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding. (Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-04-15
DOI
https://doi.org/10.1056/nejmoa2513880
Citations
1
Primary Topic
Traumatic Brain Injury and Neurovascular Disturbances
Type
article
Field-Weighted Citation Impact
22.03

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article

Asundexian for Secondary Stroke Prevention

Vaidas Matijošaitis, Thompson Robinson, Laura Heenan, Pablo F Amaya et al.
1 citations
New England Journal of Medicine
Traumatic Brain Injury and Neurovascular Disturbances
22.03
article

Asundexian for Secondary Stroke Prevention

Vaidas Matijošaitis, Thompson Robinson, Laura Heenan, Pablo F Amaya, Fan Kee Hoo, Pablo C. Colorado, Hardi Mundl, Eva Muehlhofer, Roland C. Veltkamp, Ashkan Shoamanesh, I‐Hui Lee, Mukul Sharma, 许丽珍, José Manuel Ferro, Christoph Neumann, Raed A. Joundi, Hee‐Joon Bae, Dániel Bereczki, Jeffrey L. Saver, Arne G. Lindgren, A Słowik, Lars Keller, Jonathan M. Coutinho, H. Bart van der Worp, Ivan Staikov, Peter Turčáni, Serefnur Ozturk, Karleen Schulze, Evija Miglane, Hanne Christensen, J Putaala, Michael Knoflach, Georgios Tsivgoulis, Robin Lemmens, Saule T. Turuspekova, Qiang Dong, Andrew M. Demchuk, John W. Eikelboom, Jaime Masjuan, Ronen R. Leker, Scott E. Kasner, Martin Kovar, Teruyuki Hirano, Andrea Zini, Gisele Sampaio Silva, P.N. Sylaja, Robert Mikulik, Charlotte Cordonnier, Bruce C.V. Campbell, Pierre Amarenco, Eric E. Smith, Gian Marco De Marchis, Kevin N. Sheth, Else Charlotte Sandset
article en
1 citations

Abstract

BACKGROUND: Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear. METHODS: In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding. RESULTS: Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively. CONCLUSIONS: Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding. (Funded by Bayer; OCEANIC-STROKE ClinicalTrials.gov number, NCT05686070.).

New England Journal of MedicineVol. 394(15)
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), Bayer (United States) (US), University of Leicester (GB), Inserm (FR), University of California, Los Angeles (US), The University of Melbourne (AU), University of Calgary (CA), Délégation Paris 7 (FR), University of Basel (CH), Lund University (SE), Universität Innsbruck (AT), Kyorin University (JP), Kazakh National Medical University (KZ), National and Kapodistrian University of Athens (GR), Université Paris Cité (FR), Heidelberg University (DE), 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), Frederiksberg Hospital (DK), University Hospital Heidelberg (DE), Population Health Research Institute (CA), Taipei Veterans General Hospital (TW), Seoul National University Bundang Hospital (KR), University Medical Center Utrecht (NL), Centre Hospitalier Universitaire de Lille (FR), Yale University (US), Fundación Valle del Lili (CO), Pauls Stradiņš Clinical University Hospital (LV), University Hospital Brno (CZ), Na Homolce Hospital (CZ), Centro Hospitalar Lisboa Norte (PT), Azienda USL di Bologna (IT), Istituto delle Scienze Neurologiche di Bologna (IT), St. Anne's University Hospital Brno (CZ), Skåne University Hospital (SE), Hôpital Bichat-Claude-Bernard (FR), Alfried Krupp Hospital (DE), Amsterdam University Medical Centers (NL), 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), KU Leuven (BE)
Bayer
Good health and well-being
Openalex Percentile: Top 1%
Traumatic Brain Injury and Neurovascular Disturbances
22.03
DOIOpen Access PDFOpenAlex
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