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A Study of Milvexian for Stroke Prevention

This study is looking at whether a drug called milvexian can help reduce the risk of having another stroke after someone has already experienced an ischemic stroke (a stroke caused by a blood clot) or a high-risk transient ischemic attack (TIA, sometimes called a mini-stroke). Participants will receive either milvexian or a placebo (an inactive substance) by mouth. We're looking to see if milvexian can prevent the first occurrence of another ischemic stroke over approximately 41 months. You may be able to join if you are 40 years or older and have recently had an ischemic stroke with certain symptoms or brain imaging findings. The current status of this study is unclear.

Study design
This study is comparing milvexian to a placebo in over 12,000 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 41 months to track the occurrence of an ischemic stroke.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05702034

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

Active, Not Recruiting
PHASE3Ages 40+InterventionalTreatment
Janssen Research & Development, LLC
~12,523 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:MilvexianPlacebo

At a glance

Recruiting sites
0 of 880 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of Ischemic Stroke
Measured over Up to global targeted endpoint date (approximately 41 months)

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Explore related trials

Ischemic StrokeTransient Ischemic Attack

Where it's being run

880 sites across 84 states
China78
Japan71
India54
Germany38
South Korea32
Spain32
United Kingdom29
France27

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6
Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion

Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations
Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

What this trial measures

  • Time to First Occurrence of Ischemic StrokeUp to global targeted endpoint date (approximately 41 months)

    Time to first occurrence of ischemic stroke will be reported.