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WSC 2026 | What do clinicians need to know about asundexian for secondary stroke prevention?

Mike Sharma, MD, MSc, FRCPC, McMaster University, Hamilton, Ontario, Canada, discusses key prescribing considerations for asundexian following non-cardioembolic ischemic stroke or transient ischemic attack (TIA). Prof. Sharma explains that, in the Phase III OCEANIC-STROKE trial (NCT05686070), asundexian showed good efficacy across major stroke subtypes, and that it can be used in patients with non-cardioembolic ischemic stroke with an NIHSS score of up to 15, a much broader population than in dual antiplatelet therapy trials. He highlights that, when added to antiplatelet therapy, asundexian did not increase major or intracranial bleeding and was as well tolerated as placebo. This interview took place at the 18th World Stroke Congress (WSC) in Seoul, Korea.

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Transcript

Here’s my message to general neurologists and stroke physicians. Your life is about to become easier. So with previous generations of anti-thrombotic therapy, we have to be very careful about things like the risk of hemorrhagic transformation. With asundexian, we don’t see any increase in bleeding. We also see good efficacy across major stroke subtypes. So really, for general neurologists, the question is, is it an ischemic stroke? Is it non-cardioembolic? And by that, we mean simply, is there atrial fibrillation known at this time, left ventricular thrombus, or a mechanical heart valve...

Here’s my message to general neurologists and stroke physicians. Your life is about to become easier. So with previous generations of anti-thrombotic therapy, we have to be very careful about things like the risk of hemorrhagic transformation. With asundexian, we don’t see any increase in bleeding. We also see good efficacy across major stroke subtypes. So really, for general neurologists, the question is, is it an ischemic stroke? Is it non-cardioembolic? And by that, we mean simply, is there atrial fibrillation known at this time, left ventricular thrombus, or a mechanical heart valve. Any of those three things would exclude the patient if they’re not there. And the stroke size is up to an NIH of 15, which is much broader than previous trials, then it fits the criteria and it is okay to use. So I think our concerns about hemorrhage, about stroke size, about very narrow ranges of NIHSS. So the dual antiplatelet trials apply only to an NIHSS up to four or five, depending on what trial you look at. All of those now go by the wayside. Don’t have to worry about the stroke subtype. It just becomes easier to use.

So what we’ve seen is that asundexian added to antiplatelet therapy does not increase the risk of bleeding over antiplatelet therapy alone. And this was for ISTH major bleeding, but also for intracranial bleeding and intracerebral bleeding, importantly. Now, one thing to know is this doesn’t mean that no one will ever bleed while taking it. People who are taking nothing bleed. People who are taking aspirin bleed. And you’ll still see those same type of bleeds. I think one of the important things for clinicians will be to tell the patient that this will not increase your risk of bleeding over what it would be with aspirin alone. And I think that’s a reasonably safe thing. Asundexian was as well tolerated as placebo. So we didn’t see an excess of adverse events. We didn’t see an excess of bleeding. There are a very small number of patients who experienced lower GI bleeding with asundexian, slightly more than with placebo. But really what that suggests is there’s a small shift in the location of bleeding rather than the increase in bleeding overall.

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Disclosures

Consultant: Bayer, Regeneron, Anthos; Speakers Bureau: Bayer; The institution of Dr. Sharma has received research support from Bayer.

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