Asundexian for Secondary Stroke Prevention.
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Sharma Mukul, Dong Qiang, Hirano Teruyuki, Kasner Scott E, Saver Jeffrey L, Masjuan Jaime, Demchuk Andrew M, Cordonnier Charlotte, Bereczki Daniel, Tsivgoulis Georgios, Veltkamp Roland, Staikov Ivan, Bae Hee-Joon, Campbell Bruce C V, Zini Andrea, Lee I-Hui, Kovar Martin, Mikulik Robert, Lemmens Robin, Ferro José M, Robinson Thompson, Christensen Hanne, Ozturk Serefnur, Leker Ronen R, Turcani Peter, Slowik Agnieszka, Amaya Pablo, Hoo Fan Kee, De Marchis Gian Marco, Knoflach Michael, Sylaja P N, Putaala Jukka, Coutinho Jonathan M, van der Worp H Bart, Miglane Evija, Matijošaitis Vaidas, Lindgren Arne G, Sampaio Silva Gisele, Sandset Else Charlotte, Turuspekova Saule T, Amarenco Pierre, Sheth Kevin N, Smith Eric E, Eikelboom John W, Joundi Raed A, Schulze Karleen, Xu Lizhen, Heenan Laura, Colorado Pablo, Keller Lars, Muehlhofer Eva, Neumann Christoph, Mundl Hardi, Shoamanesh Ashkan, OCEANIC-STROKE Investigators
Аннотация
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.).