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

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of ischemic stroke in individuals who have recently experienced an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), which is often referred to as a mini-stroke. The study is testing a medication called asundexian, also known by its code name BAY 2433334. This medication is being compared to a placebo to see if it can better prevent strokes when used alongside standard antiplatelet therapy, which is a treatment that helps prevent blood clots.

The purpose of the study is to evaluate the effectiveness and safety of asundexian in reducing the risk of ischemic strokes. Participants in the study will be randomly assigned to receive either asundexian or a placebo. The study will monitor the time it takes for participants to experience another ischemic stroke or any major bleeding events, which are significant bleeding episodes that can occur in the body. The trial will also look at other outcomes, such as the occurrence of any type of stroke, heart-related events, and overall survival rates.

Throughout the study, participants will take the medication orally in the form of a film-coated tablet. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results. The study aims to provide valuable information on whether asundexian can offer better protection against strokes compared to current treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are required to meet certain criteria, including being 18 years or older and having experienced an acute non-cardioembolic stroke or a high-risk transient ischemic attack (TIA).

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, asundexian, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

  3. Step 3

    Medication administration

    The study medication, asundexian, is administered orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol and are taken alongside standard antiplatelet therapy.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for the occurrence of ischemic strokes and any major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH).

    Regular follow-up visits are scheduled to assess the participant's health and any side effects from the medication.

  5. Step 5

    Study duration

    The study is expected to continue until October 10, 2025. Participants will remain in the study for the duration, unless they choose to withdraw or are advised to do so for health reasons.

Who can join the trial?

3 criteria

  • Participants must be **18 years of age or older**.
  • Must have experienced an **acute non-cardioembolic stroke** or a **high-risk transient ischemic attack (TIA)**. A **non-cardioembolic stroke** is a type of stroke not caused by a heart problem. A **transient ischemic attack (TIA)** is often called a "mini-stroke" and is a temporary period of symptoms similar to those of a stroke.
  • Must have **systemic or cerebrovascular atherosclerosis** or an **acute non-lacunar infarct**. **Atherosclerosis** is a condition where the blood vessels become narrowed or blocked due to a buildup of fats, cholesterol, and other substances. An **acute non-lacunar infarct** is a type of stroke that affects larger areas of the brain.

Who cannot join the trial?

10 criteria

  • Patients who have had a type of stroke called a **cardioembolic stroke**. This is a stroke caused by a blood clot that comes from the heart.
  • Patients who have a high risk of **bleeding**. This means they might bleed more easily than usual.
  • Patients who are currently taking certain medications that affect blood clotting, other than the ones allowed in the study.
  • Patients with severe liver disease. The liver is an organ that helps with digestion and cleaning the blood.
  • Patients with severe kidney disease. The kidneys are organs that help filter waste from the blood.
  • Patients who have had a recent major surgery. Surgery is an operation done by doctors to fix or remove something inside the body.
  • Patients who have a condition called **uncontrolled high blood pressure**. This means their blood pressure is too high and not being managed well with treatment.
  • Patients who are pregnant or breastfeeding. This means women who are expecting a baby or feeding a baby with breast milk.
  • Patients who have a history of **allergic reactions** to similar medications. An allergic reaction is when the body reacts badly to something, like a rash or trouble breathing.
  • Patients who are participating in another clinical trial. This means they are already part of a different study testing another treatment.
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Investigated drugs

Asundexian is an oral medication being studied for its ability to prevent ischemic strokes. It works by inhibiting a specific factor in the blood clotting process, which may help reduce the risk of stroke in patients who have recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). The trial aims to determine if asundexian is more effective than standard treatment in preventing further strokes.

What is already known about the treatment

Asundexian – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in preventing ischemic strokes in patients who have experienced an acute non-cardioembolic ischemic stroke or are at high risk of transient ischemic attacks. Asundexian is an oral FXIa inhibitor, which means it works by blocking a specific protein involved in blood clot formation, thereby reducing the risk of stroke. It is classified as an anticoagulant, and its potential benefits are being compared to a placebo in ongoing research.

Investigated diseases

  • Ischemic Stroke

    An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow. This lack of blood flow results in brain cells being deprived of oxygen and nutrients, leading to their damage or death. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of an ischemic stroke can vary, with some individuals experiencing rapid onset of symptoms, while others may have a more gradual progression. Immediate medical attention is crucial to minimize brain damage. Recovery and progression depend on the stroke's severity and the affected brain area.

  • Transient Ischemic Attack (TIA)

    Often referred to as a mini-stroke, a transient ischemic attack occurs when there is a temporary reduction in blood flow to a part of the brain. This results in stroke-like symptoms that typically last for a few minutes to a few hours but do not cause permanent damage. Common symptoms include sudden weakness, numbness, or difficulty speaking. TIAs are often warning signs of a potential future stroke and indicate underlying issues with blood flow. The symptoms usually resolve quickly, but they should not be ignored. Prompt medical evaluation is essential to address risk factors and prevent a full-blown stroke.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503793-20-00Protocol code20604Estimated enrolment12 008 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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