Overviewing Phase 3 OCEANIC-STROKE Trial of Asundexian in Secondary Stroke Prevention: Mike Sharma, MD, MSc

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"We now have a treatment, asundexian, which can reduce [the] risk of [stroke] recurrence substantially, giving [patients] more confidence in the future, and less fear and risk of recurrence."

Asundexian (Bayer) is a novel investigational treatment that inhibits a clotting protein called Factor XI (FXIa), which is involved in producing large blood clots that can block blood vessels. Preliminary late-breaking data of the phase 3 OCEANIC-STROKE study (NCT05686070), presented at the recently concluded 2026 International Stroke Conference (ISC), held February 4-6, in New Orleans, Louisiana, showed that patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack treated with asundexian displayed a reduction in the risk of a second ischemic or clot-caused stroke without raising bleeding concerns.^1,2

The phase 3 international OCEANIC-STROKE trial evaluated the efficacy and safety of adding daily asundexian to standard antiplatelet therapy in more than 12,300 patients with a recent noncardioembolic ischemic stroke or a high-risk transient ischemic attack. In the study, participants were randomized to receive either asundexian or a placebo in addition to standard antiplatelet therapy. The primary objective of the study was to determine if the combination of both could reduce the risk of recurrent ischemic stroke without increasing the incidence of major bleeding or other adverse events.

Following the late-breaking release, principal investigator Mike Sharma, MD, MSc, professor of medicine at McMaster University, spoke with NeurologyLive^® to further discuss the findings from OCEANIC-STROKE. Sharma noted that the treatment reduced recurrent stroke risk by 26% across stroke subtypes and patient subgroups, without an associated increase in major or minor hemorrhage. Above all, he emphasized the potential for asundexian to shift the paradigm in secondary stroke prevention by offering sustained benefit without the bleeding tradeoffs seen with other antithrombotic strategies.

Click here for more coverage of ISC 2026.

REFERENCES
1. New medication may reduce chances of a second clot-caused stroke without bleeding risk. News release. American Stroke Association. February 5, 2026. Accessed February 19, 2026. https://newsroom.heart.org/news/new-medication-may-reduce-chances-of-a-second-clot-caused-stroke-without-bleeding-risk
2. Bayer’s asundexian demonstrated a substantial, 26 percent reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack with no increase in ISTH major bleeding versus placebo. News release. Bayer. February 5, 2026. Accessed February 19, 2026. https://www.bayer.com/media/en-us/bayers-asundexian-demonstrated-a-substantial-26-percent-reduction-in-stroke-after-a-non-cardioembolic-ischemic-stroke-or-high-risk-transient-ischemic-attack-with-no-increase-in-isth-major-bleeding-versus-placebo/