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Asundexian for Secondary Stroke Prevention.

Mukul Sharma1, Qiang Dong2, Teruyuki Hirano3

  • 1McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada.

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|April 15, 2026
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Summary

Asundexian significantly reduced recurrent ischemic stroke risk in patients treated with antiplatelet therapy. This novel factor XI inhibitor demonstrated efficacy without increasing major bleeding events, offering a promising secondary stroke prevention strategy.

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Area of Science:

  • Cardiology
  • Neurology
  • Pharmacology

Background:

  • Patients with noncardioembolic ischemic stroke or TIA face recurrent stroke risk.
  • Low factor XI levels correlate with reduced ischemic stroke risk.
  • Asundexian targets activated factor XI, suggesting potential therapeutic benefits.

Purpose of the Study:

  • To evaluate if asundexian, added to antiplatelet therapy, improves secondary stroke prevention compared to antiplatelet therapy alone.
  • To assess the efficacy and safety of asundexian in patients with noncardioembolic ischemic stroke or high-risk TIA.

Main Methods:

  • Phase 3, double-blind, randomized trial involving 12,327 patients.
  • Patients received either asundexian (50 mg daily) or placebo, alongside antiplatelet therapy.
  • Primary efficacy endpoint was ischemic stroke; primary safety endpoint was major bleeding.

Main Results:

  • Asundexian group showed a lower incidence of ischemic stroke (6.2% vs. 8.4%, P<0.001).
  • Key secondary outcomes, including composite cardiovascular events, were also reduced in the asundexian group.
  • Major bleeding rates were similar between asundexian (1.9%) and placebo (1.7%) groups.

Conclusions:

  • Asundexian (50 mg daily) effectively lowers ischemic stroke and major cardiovascular event risks in patients on antiplatelet therapy.
  • The addition of asundexian did not increase the risk of major bleeding.
  • Asundexian represents a safe and effective option for secondary stroke prevention.