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

NCT05702034
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
12,523
clinicaltrials.gov
Lead sponsor
Janssen Research & Development, LLC
clinicaltrials.gov
Start date
2023-02-15
clinicaltrials.gov
Number of sites
880
clinicaltrials.gov

Summary
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
clinicaltrials.gov
Acronym
LIBREXIA-STROK
clinicaltrials.gov
Short title
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
clinicaltrials.gov
Official 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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2026-10-15
clinicaltrials.gov
First posted
2023-01-27
clinicaltrials.gov
Registry last updated
2026-08-28
clinicaltrials.gov
Primary completion date
2026-10-15
clinicaltrials.gov
Start date
2023-02-15
clinicaltrials.gov

Actual participants
12,523
clinicaltrials.gov
Participants
12,523
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
880
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Janssen Research & Development, LLC
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05702034
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05702034
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Ischemic Stroke

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

    Time to first occurrence of ischemic stroke will be reported.

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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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).

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Banner Desert Medical CenterMesa, United States
  • University of ArizonaTucson, United States
  • Plaza Neuroscience ClinicFayetteville, United States
  • Alta Bates Medical Center Cancer CenterBerkeley, United States
  • Providence Saint Joseph Medical Center - Cancer CenterBurbank, United States
  • Mills Peninsula Health ServicesBurlingame, United States
  • Sutter Health - Eden Medical CenterCastro Valley, United States
  • Neurology Center of North Orange CountyFullerton, United States
  • Glendale Adventist Medical CenterGlendale, United States
  • UC Irvine Healthcare CenterIrvine, United States
  • Sharp Grossmont HospitalLa Mesa, United States
  • Long Beach MemorialLong Beach, United States
  • Kaiser Permanente Los Angeles Medical CenterLos Angeles, United States
  • Mission Hospital Regional Medical CenterMission Viejo, United States
  • Hoag Memorial HospitalNewport Beach, United States
  • Stanford Stroke CenterPalo Alto, United States
  • Kaiser Permanente 1Redwood City, United States
  • University of California Davis Health SystemSacramento, United States
  • Kaiser PermanenteSacramento, United States
  • California Pacific Medical CenterSan Francisco, United States
  • Pacific Neuroscience InstituteSanta Monica, United States
  • Harbor Ucla Medical CenterTorrance, United States
  • Providence Little Company of MaryTorrance, United States
  • PIH Health HospitalWhittier, United States
  • University of ColoradoAurora, United States

And 855 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-501176-26-00
  • 70033093STR3001
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)