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Evaluating milvexian for preventing recurrent ischemic strokes after an acute event

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Phase 3 Interventional Janssen Research & Development, LLC · NCT05702034

This study is testing if a new medication called milvexian can help prevent more strokes in people who have just had an ischemic stroke or a high-risk TIA.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment15000 (estimated)
Ages40 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations834 sites (Mesa, Arizona and 833 other locations)
Trial IDNCT05702034 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy of milvexian, an investigational medication, in reducing the risk of recurrent ischemic strokes in participants who have recently experienced an acute ischemic stroke or a high-risk transient ischemic attack (TIA). Participants will be randomized to receive either milvexian or a placebo within 48 hours of their event. The study will monitor outcomes related to stroke recurrence and overall neurological health. The goal is to determine if milvexian can provide a significant benefit over standard care.

Who should consider this trial

Good fit: Ideal candidates include individuals who have experienced an acute ischemic stroke or high-risk TIA with specific eligibility criteria related to their neurological status.

Not a fit: Patients who have not experienced an ischemic stroke or TIA, or those with severe neurological deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of recurrent strokes, improving long-term outcomes for patients.

How similar studies have performed: Previous studies have shown promise in using anticoagulants and other interventions for stroke prevention, but the specific use of milvexian in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Mesa, Arizona and 833 other locations

+784 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic StrokeIschemic Attack, Transient
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.