A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05757869

Run by

Janssen Research & Development, LLC

People needed

20284

Starts

2023-04-11

Expected to finish

2026-10-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bugat Pal Korhaz — Gyöngyös, Hungary
• ZGT Cardioresearch — Almelo, Netherlands
• Changhua Christian Hospital — Changhua, Taiwan
• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States
• Ascension St. Vincent's Health System — Birmingham, Alabama, United States
• SEC Clinical Research — Dothan, Alabama, United States
• HH Heart Center and Heart Center — Huntsville, Alabama, United States
• CB Flock Research Corporation — Mobile, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Valleywise Health Medical Center — Phoenix, Arizona, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Arizona Heart Hospital — Phoenix, Arizona, United States
• HonorHealth Neurology 1 — Scottsdale, Arizona, United States
• HonorHealth Neurology — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Bakersfield Memorial Hospital — Bakersfield, California, United States
• Vitality Clinical Research — Beverly Hills, California, United States
• Chula Vista Cardiac Clinic — Chula Vista, California, United States
• Sharp Chula Vista Medical Center — Chula Vista, California, United States
• Mission Cardiovascular Research Institute — Fremont, California, United States
• Paradise Clinical Research Group LLC — Glendora, California, United States
• Miller Children's at Long Beach Medical Center — Long Beach, California, United States
• Los Angeles Cardiology Associates — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Watson Clinic — Lakeland, Florida, United States

Full record on ClinicalTrials.gov

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