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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Apixaban Placebo; Drug: Milvexian; Drug: Placebo; Drug: Apixaban

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

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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: Placebo

Drug: Milvexian

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