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NCT Number: NCT05702034

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

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundacion Favaloro, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milvexian

Drug

Milvexian will be administered orally.

Other names: JNJ-70033093, BMS-986177

Placebo

Drug

Placebo will be administered orally

Primary outcomes

  1. Time to First Occurrence of Ischemic Stroke

    Time frame: Up to global targeted endpoint date (approximately 41 months)

    Time to first occurrence of ischemic stroke will be reported.

Secondary outcomes

  1. Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke

    Time frame: Up to global targeted endpoint date (approximately 41 months)

    Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported.

  2. Time to First Occurrence of Ischemic Stroke

    Time frame: Up to Day 90

    Time to first occurrence of ischemic stroke in the first 90 days will be reported.

  3. Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)

    Time frame: Up to global targeted endpoint date (approximately 41 months)

    Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT).

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Bristol Myers Squibb Company (BMS)

Registry information

Official study title

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

Acronym: LIBREXIA-STROK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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