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Asundexian

Clinical trials are studying Asundexian in people with stroke risk, atrial fibrillation, and in healthy volunteers. These studies look at how well it may prevent blood clots and stroke, and how safe it is compared with other treatments or placebo. One trial also checks how food and a pediatric formulation affect blood levels.

Table of contents

Clinical trials overview

These studies are testing Asundexian in different groups of people who may have a higher risk of clot-related problems.[1][2][3] The trial data include two large Phase 3 studies and one smaller Phase 1 study.[1][2][3]

The main research goal in the Phase 3 trials is to see whether Asundexian can help prevent stroke or related clot events better than the comparison treatment, while also checking major bleeding.[1][2] The Phase 1 study looks at blood levels after a single dose and how food changes those levels.[3]

Stroke and TIA study

NCT05686070 is a completed Phase 3 trial called OCEANIC-STROKE.[1] It studied people after an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, which is a short-lasting stroke-like event often called a mini stroke.[1]

The study compared oral BAY 2433334, which is Asundexian, with placebo on top of background antiplatelet therapy.[1] The brief summary says the trial wanted to see whether Asundexian was superior to placebo in reducing ischemic stroke in these patients.[1]

The main outcomes were time to first ischemic stroke and time to first ISTH major bleeding, which means serious bleeding defined by the International Society on Thrombosis and Hemostasis.[1]

Atrial fibrillation study

NCT05643573 is another completed Phase 3 trial.[2] It studied people with atrial fibrillation, a heart rhythm problem that can raise the risk of stroke, and who were at risk for stroke.[2]

This study compared Asundexian with apixaban, a standard blood-thinning treatment used in this setting.[2] The trial also used placebo versions of the study treatments to keep the comparison fair and blinded.[2]

The trial aimed to show that Asundexian was at least not worse than apixaban for preventing stroke or systemic embolism, and it also measured whether Asundexian reduced major bleeding.[2] A composite outcome, meaning a combined result, also looked at stroke, systemic embolism, or major bleeding together.[2]

Healthy participant study

Trial 2025-523677-41-00 is an authorised Phase 1 study in healthy participants.[3] It is much smaller than the Phase 3 studies and includes 18 people.[3]

This study looks at the amount of Asundexian in the blood after a single oral dose and compares a pediatric formulation with the tablet form in the fasted state.[3] It also checks how a high-fat, high-calorie meal changes the blood levels of the pediatric formulation.[3]

The main measurements are Cmax, which is the highest blood level reached, and AUC, which shows total drug exposure over time.[3] The study also measures AUC(0-tlast), which is exposure from the start until the last measured time point.[3]

Endpoints and measures

The stroke and TIA trial focused on the time until the first ischemic stroke and the time until the first ISTH major bleeding event.[1] These endpoints help researchers understand both benefit and safety in the same study.[1]

The atrial fibrillation trial used a combined endpoint of stroke or systemic embolism, plus major bleeding outcomes, to balance effectiveness and safety.[2] This design helps show whether a treatment lowers clot risk without causing too much serious bleeding.[2]

The Phase 1 study used blood-level measurements instead of clinical outcomes like stroke, because early studies often focus on how the body handles a treatment.[3] The food-effect part is important because meals can sometimes change how much of a treatment reaches the blood.[3]

Trial status and size

The two large studies, NCT05686070 and NCT05643573, are both listed as completed.[1][2] They enrolled 12,008 and 17,460 participants, respectively, showing that these were very large stroke-prevention trials.[1][2]

The healthy participant study is authorised and much smaller, with 18 participants.[3] Together, these trials show that Asundexian has been studied both in patients with serious clot-related risks and in healthy volunteers for early blood-level testing.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05686070Phase 3Prevention of ischemic stroke after acute non-cardioembolic ischemic stroke or high-risk transient ischemic attackCompleted12008
NCT05643573Phase 3Prevention of stroke or systemic embolism in atrial fibrillationCompleted17460
2025-523677-41-00Phase 1Prevention of thromboembolic eventsAuthorised18

FAQ

  • What conditions are being studied in Asundexian trials? The trials study prevention of ischemic stroke after a recent stroke or high-risk transient ischemic attack, and prevention of stroke or systemic embolism in atrial fibrillation. One phase 1 study in healthy participants looks at blood levels and the effect of food.
  • Who can join these studies? The target groups include people after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack, people with atrial fibrillation at risk for stroke, and healthy participants. Each trial has its own entry rules.
  • What phases are the Asundexian trials? Two large studies are Phase 3 trials, which usually test how well a treatment works in large groups of people. One smaller study is Phase 1, which focuses on how the body handles the treatment.
  • What are the main goals of these trials? The Phase 3 trials measure whether Asundexian lowers the risk of stroke or systemic embolism and whether it causes major bleeding. The Phase 1 trial measures blood levels after a single dose and how a high-fat meal changes those levels.
  • Are these trials completed or still ongoing? The two Phase 3 trials listed here are completed. The Phase 1 study is authorised.

Ongoing Clinical Trials on Asundexian

  • A study to compare how asundexian is absorbed in healthy adults using different formulations and the effect of food for the prevention of blood clots.

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Asundexian and Apixaban for Preventing Stroke in Adults with Atrial Fibrillation at Risk for Stroke

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Estonia +16

  • Study on Asundexian for Preventing Ischemic Stroke in Adults After a Stroke or High-Risk Mini-Stroke

    Not recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Finland +14

Glossary

  • Acute ischemic stroke: A sudden stroke caused by a blocked blood vessel in the brain.
  • Transient ischemic attack (TIA): A short-lasting stroke-like event, sometimes called a mini stroke, caused by a temporary blockage.
  • Non-cardioembolic: Not caused by a clot coming from the heart.
  • Atrial fibrillation: An irregular and often fast heartbeat that can raise the risk of stroke.
  • Systemic embolism: A clot that blocks blood flow in another part of the body, not the brain.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Phase 1: An early study phase that often looks at how the body handles a treatment.
  • Phase 3: A later study phase that tests how well a treatment works in larger groups.
  • Primary outcome: The main result the study is designed to measure.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Cmax: The highest level of the treatment measured in the blood.
  • AUC: A measure of total drug exposure in the blood over time.

References