A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

NCT05757869 · tracked via the Priya Life Science UK tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 3

Started

2023-04-11

Last updated

2026-08-28

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

MilvexianApixabanPlaceboApixaban Placebo

Milvexian: Milvexian will be administered orally.

Apixaban: Apixaban will be administered orally.

Placebo: Milvexian matching milvexian placebo will be administered orally.

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism — Up to 4 years
Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.

Trial sites (1052)

Facility	City	Region
Advanced Cardiovascular, LLC	Alexander City	Alabama
Ascension St. Vincent's Health System	Birmingham	Alabama
SEC Clinical Research	Dothan	Alabama
HH Heart Center and Heart Center	Huntsville	Alabama
CB Flock Research Corporation	Mobile	Alabama
Mercy Gilbert Medical Center	Gilbert	Arizona
Valleywise Health Medical Center	Phoenix	Arizona
Arizona Arrhythmia Research Center	Phoenix	Arizona
Arizona Heart Hospital	Phoenix	Arizona
HonorHealth Neurology 1	Scottsdale	Arizona
HonorHealth Neurology	Scottsdale	Arizona
Arkansas Heart Hospital	Little Rock	Arkansas
Bakersfield Memorial Hospital	Bakersfield	California
Vitality Clinical Research	Beverly Hills	California
Chula Vista Cardiac Clinic	Chula Vista	California
Sharp Chula Vista Medical Center	Chula Vista	California
Mission Cardiovascular Research Institute	Fremont	California
Paradise Clinical Research Group LLC	Glendora	California
Miller Children's at Long Beach Medical Center	Long Beach	California
Los Angeles Cardiology Associates	Los Angeles	California
University of Southern California	Los Angeles	California
Merced Vein and Vascular Center	Merced	California
Radin Cardiovascular Medical Group	Newport Beach	California
California Medical Research Associates, Inc.	Northridge	California
Valley Clinical Trials, Inc.	Northridge	California
Desert Oasis Health Care	Palm Springs	California
Havana Research Institute LLC	Pasadena	California
Eisenhower Desert Cardiology Center	Rancho Mirage	California
Stanford Health Care	Redwood City	California
San Diego Cardiac Center	San Diego	California
Syrentis Clinical Research	Santa Ana	California
Ramin Manshadi, MD	Stockton	California
UCLA School of Medicine	Torrance	California
Cardiology Associates Medical Group	Ventura	California
North County Internal Medicine	Vista	California
John Muir Physician Network Clin. Research Center	Walnut Creek	California
Aurora Denver Cardiology Associates	Aurora	Colorado
Aurora Denver Cardiology Associates 1	Denver	Colorado
Paradigm Clinical Research Centers, Inc.	Wheat Ridge	Colorado
Bridgeport Hospital	Bridgeport	Connecticut

+ 1012 more sites — see the full list on the official registry below.

On this site

📄 Eliquis (apixaban) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05757869 on ClinicalTrials.gov ↗ ← All trials in the UK