A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

NCT05757869 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20284

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Milvexian

Milvexian will be administered orally.

DRUG

Apixaban

Apixaban will be administered orally.

DRUG

Placebo

Milvexian matching milvexian placebo will be administered orally.

DRUG

Apixaban Placebo

Apixaban matching apixaban placebo will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757869 on ClinicalTrials.gov