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Study on Milvexian and Apixaban for Preventing Stroke in Patients with Atrial Fibrillation

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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 Atrial Fibrillation, a common heart condition that causes an irregular and often rapid heart rate. The study is comparing two treatments: Milvexian, an oral medication that works by inhibiting a specific protein involved in blood clotting, and Apixaban, a well-known medication used to prevent blood clots. The purpose of the study is to determine if Milvexian is as effective as Apixaban in preventing strokes and other related complications in people with Atrial Fibrillation.

Participants in the study will be randomly assigned to one of two treatment groups: one group will receive Milvexian and a matching placebo that looks like Apixaban, while the other group will receive Apixaban and a matching placebo that looks like Milvexian. This means that all participants take both an active medication and a placebo, allowing the study to be conducted in a double-blind manner, so that neither the participants nor the researchers know which active treatment is being administered.

The study will last for up to 48 weeks. During this period, participants will take their assigned medication orally. Some participants may also receive a solution for infusion, known as Ondexxya, to help manage any potential side effects.

The main goal is to monitor the time it takes for participants to experience a stroke or a non-CNS systemic embolism, which is a type of blood clot that occurs outside the brain and spinal cord. Secondary goals include observing the occurrence of major bleeding and other cardiovascular events. The study aims to provide valuable information on the safety and effectiveness of Milvexian compared to Apixaban, potentially offering a new treatment option for individuals with Atrial Fibrillation.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication assignment

    Upon joining the study, an assignment is made to one of two groups to compare the effectiveness of a new medicine called milvexian against a standard medicine called apixaban.

    The study uses a double-dummy method, which means two types of pills are taken to ensure the treatment and the comparison are equal in appearance and routine.

  2. Step 2

    Medication administration

    If assigned to the milvexian group, the daily routine involves taking milvexian (200 mg) orally and a placebo (a pill with no active medicine) that looks like apixaban.

    If assigned to the apixaban group, the daily routine involves taking apixaban orally and a placebo that looks like milvexian.

    The specific dosage of apixaban may be 5 mg or 10 mg, depending on the assigned group and medical requirements.

    Additional background medication, such as apixaban (2.5 mg or 5 mg), may be continued as part of the medical regimen.

  3. Step 3

    Monitoring and clinical evaluation

    During the trial, the focus is on monitoring the time until any occurrence of a stroke or systemic embolism (a condition where a blood clot blocks an artery in the body, excluding the central nervous system).

    The safety of the medications is monitored by tracking the occurrence of major bleeding or non-major bleeding.

    The trial also tracks other health events, including cardiovascular death (death related to heart or blood vessel issues), myocardial infarction (a heart attack), and acute limb ischemia (a sudden decrease in blood flow to a limb).

Who can join the trial?

7 criteria

  • You must be at least 18 years old.
  • You must be in a steady medical state and suitable for long-term antithrombotic treatment, which is medicine used to prevent blood clots from forming.
  • You must have atrial fibrillation, which is an irregular and often rapid heart rhythm that can cause poor blood flow.
  • You must be able to receive anticoagulation therapy, which is a type of medication that helps prevent blood clots.
  • You must meet at least one of the following risk categories:
  • Category A: You are 75 years of age or older, or you have a history of stroke (when blood flow to part of the brain is cut off), silent brain infarcts (small areas of brain tissue death that show no symptoms), or cerebral microbleeds (tiny leaks of blood in the brain).
  • Category B: You have at least two of the following: being between 65 and 74 years old, hypertension (high blood pressure), diabetes mellitus (a condition affecting how your body uses blood sugar), atherosclerotic vascular disease (hardening of the arteries), or heart failure (a condition where the heart cannot pump blood as well as it should).

Who cannot join the trial?

3 criteria

  • You have atrial fibrillation (an irregular and often rapid heart rate that can cause poor blood flow) along with hemodynamically significant valve disease, which means a heart valve problem that is serious enough to affect how your heart pumps blood throughout your body.
  • You have a heart valve condition that might require surgical valve replacement (a surgery to take out a damaged heart valve and put in a new one) while the study is ongoing.
  • You have any medical condition, other than atrial fibrillation, that requires chronic anticoagulation (the long-term use of blood-thinning medication to prevent blood clots).
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Investigated drugs

  • JNJ-70033093

    is an experimental medicine being tested in this study to see if it can help prevent strokes and blood clots in people with an irregular heartbeat called atrial fibrillation.

  • Eliquis

    is a medication used as a comparison in this trial to evaluate how well the experimental treatment works. It is an oral medicine that helps prevent the formation of dangerous blood clots.

  • Ondexxya

    is a medication administered through an IV (intravenous) infusion that is used as a background therapy in this study.

What is already known about the treatment

  • Apixaban

    This medication is taken as an oral tablet to help prevent blood clots in patients with irregular heartbeats like atrial fibrillation. It is a well-established medicine that works by blocking a specific protein in the blood called Factor Xa, which stops the clotting process at a key step. By inhibiting this protein, the drug reduces the risk of dangerous strokes and other blood clots. This substance is classified as an oral anticoagulant.

  • Andexanet alfa

    This medicine is administered as a powder through an intravenous infusion to act as an emergency reversal agent. It is used in medical settings to quickly counteract the effects of certain blood-thinning medications when excessive bleeding occurs. The drug works by acting like a sponge that soaks up the anticoagulant molecules in the bloodstream, preventing them from blocking clotting proteins. It is classified as a reversal agent for anticoagulants.

  • Milvexian

    This is an investigational medication taken orally in tablet form that is currently being studied in clinical trials. It is designed to prevent blood clots by targeting and inhibiting a protein known as Factor XIa, which plays a role in the blood's clotting cascade. By blocking this specific protein, the drug aims to reduce the risk of stroke without significantly increasing the risk of bleeding. It is classified as a Factor XIa inhibitor.

Investigated diseases

Atrial Fibrillation - This is a type of irregular heartbeat where the upper chambers of the heart beat out of sync with the lower chambers. It occurs when the electrical signals that control the heart rate become disorganized. As the condition progresses, the heart may beat too fast or with an irregular rhythm. This irregularity can lead to blood pooling in the heart chambers. Over time, this process increases the likelihood of blood clots forming.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501419-15-00Protocol code70033093AFL3002Estimated enrolment18 339 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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