The trial is taking place at:
A

Ascension | Ascension Texas Cardiovascular

Veeva-enabled site

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

J

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Placebo
Drug: Apixaban Placebo
Drug: Apixaban
Drug: Milvexian

Study type

Interventional

Funder types

Industry

Identifiers

NCT05757869
CR109220
2022-501419-15-00 (Registry Identifier)
70033093AFL3002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

15,500 participants in 2 patient groups

Milvexian
Experimental group
Description:
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.
Treatment:
Drug: Milvexian
Drug: Placebo
Apixaban
Active Comparator group
Description:
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.
Treatment:
Drug: Apixaban
Drug: Apixaban Placebo

Trial contacts and locations

672

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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