Factor XIa Inhibitor Asundexian Reduces Recurrent Stroke Without Increasing Bleeding

The OCEANIC-STROKE trial shows a major achievement in separating stroke reduction from bleeding risk.

Published on Feb. 6, 2026

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The factor XIa inhibitor asundexian significantly reduced the occurrence of recurrent ischemic stroke in patients with recent noncardioembolic stroke or high-risk transient ischemic attack (TIA) treated with antiplatelet therapy, without causing increased bleeding. The reduction in recurrent stroke, including disabling or fatal events, was evident early and persisted throughout the treatment period, with a consistent effect across all subgroups. There was no increase in any type of bleeding, including major, minor, or intracranial bleeding.

Why it matters

Patients who have had a recent stroke or high-risk TIA remain at substantial risk for recurrence, yet options for secondary stroke prevention are limited. While cardioembolic stroke can be effectively treated with anticoagulation, the majority of strokes — which are noncardioembolic — are typically managed long term with single antiplatelet therapy, most commonly aspirin or clopidogrel. This trial represents a major achievement in developing a new antithrombotic approach that can reduce stroke risk without the bleeding risk associated with other antithrombotic agents.

The details

In the OCEANIC-STROKE trial, 12,300 patients who were within 72 hours of a noncardioembolic stroke (95%) or high-risk TIA (5%), managed with single or dual antiplatelet therapy, were randomly assigned to receive asundexian 50 mg administered orally once daily or placebo. The primary endpoint of recurrent ischemic stroke was significantly reduced with asundexian, with an absolute risk reduction of 1.9% at 1 year. Secondary efficacy endpoints, including ischemic and hemorrhagic stroke, cardiovascular death/myocardial infarction (MI)/stroke, all-cause mortality/MI/stroke, and disabling/fatal stroke, were also reduced. The primary safety outcome of major bleeding was similar between groups.

  • The OCEANIC-STROKE trial was conducted in patients within 72 hours of a noncardioembolic stroke or high-risk TIA.
  • The trial results were presented on February 5, 2026 at the International Stroke Conference (ISC).

The players

Asundexian

A factor XIa inhibitor developed by Bayer AG.

Mike Sharma, MD

Lead study investigator, professor of medicine at McMaster University and senior scientist at the Population Health Research Institute in Hamilton, Ontario, Canada.

Joseph Broderick, MD

Director of the UC Gardner Neuroscience Institute at the University of Cincinnati in Cincinnati, who provided commentary on the trial results.

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What they’re saying

“This is a major achievement to separate the bleeding from the stroke reduction. It's a complete shift in the paradigm. We haven't seen this before with antithrombotics.”

— Mike Sharma, MD, Lead study investigator (Medscape Medical News)

“We now have something that works on top of antiplatelets, that very safely reduces the occurrence of stroke substantially, and really doesn't have the bleeding price to pay that we've seen in other trials with antithrombotics.”

— Mike Sharma, MD, Lead study investigator (Medscape Medical News)

“We have been trying to use DOAC-type drugs in these stroke patients without a clear cardiac source, but the trials have not shown net benefit because of an increased bleeding risk, so this is obviously a great step forward.”

— Joseph Broderick, MD, Director, UC Gardner Neuroscience Institute (Medscape Medical News)

What’s next

The FDA may require two positive trials for a new agent like asundexian before approving it. Cost will also be an important consideration, as new medications are typically expensive.

The takeaway

This trial represents a major breakthrough in developing a new antithrombotic approach that can significantly reduce the risk of recurrent stroke without the bleeding risk associated with other antithrombotic agents. If approved, asundexian could become an important new option for secondary stroke prevention, especially for patients with noncardioembolic stroke who have limited treatment options.