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Study on Milvexian for Preventing Stroke in Patients with Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

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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 effects of a medication called Milvexian on preventing strokes in individuals who have experienced an Acute Ischemic Stroke or a High-Risk Transient Ischemic Attack. An acute ischemic stroke occurs when a blood clot blocks a blood vessel in the brain, leading to a sudden loss of brain function. A transient ischemic attack, often called a mini-stroke, is a temporary period of symptoms similar to those of a stroke. The study aims to determine if Milvexian can reduce the risk of having another ischemic stroke compared to a placebo.

Participants in the study will receive either Milvexian, a placebo, or other medications such as Acetylsalicylic Acid (commonly known as aspirin) and Clopidogrel, which are standard treatments for preventing blood clots. Milvexian is taken as a film-coated tablet, and the study will compare its effectiveness and safety against these other treatments. The trial will be conducted over a period of several weeks, during which participants will be monitored for any occurrences of ischemic strokes or other related health events.

The purpose of this study is to explore new ways to prevent strokes and improve the safety and effectiveness of treatments for individuals at high risk of stroke. By participating in this trial, researchers hope to gather valuable information that could lead to better prevention strategies for stroke patients in the future.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria such as age and medical history related to acute ischemic stroke or high-risk transient ischemic attack.

    Randomization occurs within 48 hours of the onset of the event, ensuring that all necessary medical evaluations and imaging are completed.

  2. Step 2

    Medication administration

    Participants receive either milvexian or a placebo. Milvexian is an oral medication taken in the form of a film-coated tablet.

    The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial duration.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the effectiveness and safety of the medication. This includes tracking the time to the first occurrence of an ischemic stroke.

    Additional assessments may include monitoring for any cardiovascular events or other related health issues.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by November 2026. Participants will be informed of the study's findings and any relevant health information.

    Upon completion, participants may receive guidance on further medical care or follow-up as needed.

Who can join the trial?

10 criteria

  • Must be 40 years of age or older.
  • Must have had an Ischemic Stroke (a type of stroke caused by a blockage in the blood supply to the brain) with a NIHSS score of 7 or less (a scale used to measure the severity of a stroke) and at least one of the following:
    • Ongoing signs or symptoms of the stroke at the time of joining the study.
    • An acute brain lesion (damage) seen on a brain scan.
    • Received treatment to dissolve or remove the blockage in the brain.
    • Must have had a Transient Ischemic Attack (TIA) (a temporary period of symptoms similar to those of a stroke) with complete symptom resolution and no brain damage seen on a brain scan, and an ABCD2 Score of 6 or more (a score used to predict the risk of stroke after a TIA).
    • Must be able to join the study as soon as possible after confirming eligibility and within 48 hours of the stroke or TIA. If the stroke happened during sleep, within 48 hours from the last time the person was known to be normal.
    • If treated with medication or a procedure to remove the blockage, must wait at least 24 hours after treatment and not more than 48 hours after the stroke or TIA to join the study. A brain scan must show no bleeding, and blood tests must be within safe limits.
    • Must be on or planning to start antiplatelet treatment (medication to prevent blood clots) as per guidelines. If using ASA (Aspirin), it should be a low dose (75 to 100 mg/day). A loading dose (initial higher dose) of antiplatelet agents is allowed.
    • If female, must either:
      • Not be able to become pregnant, or
      • Be able to become pregnant and use a highly effective method of birth control (less than 1% chance of failure per year) and agree to continue using it until 4 days after the last dose of the study medication.

Who cannot join the trial?

8 criteria

  • Patients who have had a recent **major surgery**. This means a big operation that was done not long ago.
  • Patients with a history of **bleeding disorders**. These are conditions where the blood does not clot properly, leading to excessive bleeding.
  • Patients who are currently taking **anticoagulant medications**. These are drugs that help prevent blood clots but can increase the risk of bleeding.
  • Patients with **severe liver disease**. This is when the liver is not working well, which can affect how the body processes medications.
  • Patients with **uncontrolled high blood pressure**. This means blood pressure that is too high and not being managed with treatment.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients with a known allergy to the study medication or its ingredients. This means they have had a bad reaction to the drug or something in it before.
  • Patients who have participated in another clinical trial recently. This is to avoid any interference with the results of the study.
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Investigated drugs

Milvexian is a medication being studied to see if it can help prevent strokes. It works by blocking a specific part of the blood clotting process, which might reduce the risk of having another stroke. This medication is taken by mouth and is being tested to see if it is safe and effective for people who have had a recent stroke or a temporary stroke-like event called a transient ischemic attack. The goal is to find out if it can lower the chances of having another stroke compared to not taking the medication.

What is already known about the treatment

Milvexian – Milvexian is an oral medication taken by mouth, designed to prevent strokes in people who have had an acute ischemic stroke or a high-risk transient ischemic attack. It is currently being studied in clinical trials to determine its effectiveness and safety for this purpose. The main way it works is by blocking a specific protein in the blood called Factor XIa, which plays a role in blood clot formation. By inhibiting this protein, Milvexian helps reduce the risk of new clots forming, which can lead to strokes. It belongs to a class of drugs known as Factor XIa inhibitors.

Investigated diseases

  • Acute Ischemic Stroke

    Acute ischemic stroke occurs when a blood vessel supplying blood to the brain is obstructed, leading to a sudden loss of brain function. This blockage is often due to a blood clot that forms in the arteries leading to the brain. As a result, the affected area of the brain is deprived of oxygen and nutrients, causing brain cells to begin dying within minutes. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. The progression of the disease can lead to significant neurological damage if blood flow is not restored quickly. The severity and specific symptoms depend on the location and extent of the blockage in the brain.

  • High-Risk Transient Ischemic Attack

    A high-risk transient ischemic attack (TIA) is often referred to as a "mini-stroke" and 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. The symptoms are similar to those of a stroke, such as sudden weakness, numbness, or difficulty speaking, but they resolve completely within 24 hours. High-risk TIAs are considered a warning sign that a more severe stroke may occur in the future. The risk factors for a high-risk TIA include high blood pressure, high cholesterol, and diabetes. The progression involves the temporary blockage of blood flow, which, if not addressed, can lead to a full-blown stroke.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501176-26-00Protocol code70033093STR3001Estimated enrolment16 305 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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