A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

NCT05757869
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
20,284
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2023-04-11
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Number of sites
1,052
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Summary
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.
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Acronym
LIBREXIA-AF
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Short title
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
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Official title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-12-08
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First posted
2023-03-07
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Registry last updated
2026-08-28
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Primary completion date
2026-12-08
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Start date
2023-04-11
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Actual participants
20,284
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Participants
20,284
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Participant count basis
Actual
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Protocol amendments
9
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Number of sites
1,052
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05757869
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ClinicalTrials.gov ID
NCT05757869
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism

    Timeframe: Up to 4 years

    Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.

  1. Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding

    Timeframe: Up to 4 years

    Time to the first occurrence of ISTH major bleeding will be reported.

  2. Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding

    Timeframe: Up to 4 years

    Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported.

  3. Time to the First Occurrence of Composite Endpoint of Stroke, Non-CNS Systemic Embolism and ISTH Major Bleeding

    Timeframe: Up to 4 years

    Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism and ISTH major bleeding will be reported.

  4. Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism

    Timeframe: Up to 4 years

    Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported.

  5. Time to CV Death

    Timeframe: Up to 4 years

    Time to CV death will be reported.

  6. Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism

    Timeframe: Up to 4 years

    Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported.

  7. Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature

    Timeframe: Up to 4 years

    Time to the first occurrence of composite endpoint of CV death, MI, stroke, ALI \[any unanticipated revascularization or amputation of ischemic limb\]), and urgent hospitalization for vascular cause of ischemic nature (including deep vein thrombosis \[DVT\] and pulmonary embolism \[PE\]) will be reported.

Sources for outcomes
clinicaltrials.gov

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

  • Minimum age of 18 years
  • Medically stable and appropriate for chronic antithrombotic treatment
  • Atrial fibrillation eligible to receive anticoagulation
  • Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure

  • Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
  • Any condition other than AF that requires chronic anticoagulation
Sources for eligibility
clinicaltrials.gov

  • Advanced Cardiovascular, LLCAlexander City, United States
  • Ascension St. Vincent's Health SystemBirmingham, United States
  • SEC Clinical ResearchDothan, United States
  • HH Heart Center and Heart CenterHuntsville, United States
  • CB Flock Research CorporationMobile, United States
  • Mercy Gilbert Medical CenterGilbert, United States
  • Valleywise Health Medical CenterPhoenix, United States
  • Arizona Arrhythmia Research CenterPhoenix, United States
  • Arizona Heart HospitalPhoenix, United States
  • HonorHealth Neurology 1Scottsdale, United States
  • HonorHealth NeurologyScottsdale, United States
  • Arkansas Heart HospitalLittle Rock, United States
  • Bakersfield Memorial HospitalBakersfield, United States
  • Vitality Clinical ResearchBeverly Hills, United States
  • Chula Vista Cardiac ClinicChula Vista, United States
  • Sharp Chula Vista Medical CenterChula Vista, United States
  • Mission Cardiovascular Research InstituteFremont, United States
  • Paradise Clinical Research Group LLCGlendora, United States
  • Miller Children's at Long Beach Medical CenterLong Beach, United States
  • Los Angeles Cardiology AssociatesLos Angeles, United States
  • University of Southern CaliforniaLos Angeles, United States
  • Merced Vein and Vascular CenterMerced, United States
  • Radin Cardiovascular Medical GroupNewport Beach, United States
  • California Medical Research Associates, Inc.Northridge, United States
  • Valley Clinical Trials, Inc.Northridge, United States

And 1,027 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-501419-15-00
  • 70033093AFL3002
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (2)