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A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation (LIBREXIA-AF)

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ClinicalTrials.gov Identifier: NCT05757869
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : April 24, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Milvexian Drug: Apixaban Drug: Placebo Drug: Apixaban Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2023
Estimated Primary Completion Date : March 5, 2027
Estimated Study Completion Date : May 5, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Milvexian
Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.
 Drug: Milvexian
Milvexian will be administered orally.

Drug: Placebo
Milvexian matching milvexian placebo will be administered orally.
Active Comparator: Apixaban
Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.
 Drug: Apixaban
Apixaban will be administered orally.

Drug: Apixaban Placebo
Apixaban matching apixaban placebo will be administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism [ Time Frame: Up to 4 years ]
    Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.


Secondary Outcome Measures :
  1. Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding [ Time Frame: 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 [ Time Frame: 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 Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism [ Time Frame: 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.

  4. Time to CV Death [ Time Frame: Up to 4 years ]
    Time to CV death will be reported.

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

  6. 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 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757869


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Bristol-Myers Squibb
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05757869    
Other Study ID Numbers: CR109220
70033093AFL3002 ( Other Identifier: Janssen Research & Development, LLC )
2022-501419-15-00 ( Registry Identifier: EUCT number )
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants