A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

Purpose

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

  • Atrial Fibrillation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Tulane University School of Medicine
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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