A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

a study on Atrial Fibrillation Heart Conditions

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation

Keywords

Atrial Fibrillation, Apixaban, Milvexian

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCLA School of Medicine accepting new patients
    Torrance California 90502 United States
  • Vitality Clinical Research accepting new patients
    Beverly Hills California 90211 United States
  • Los Angeles Cardiology Associates accepting new patients
    Los Angeles California 90017 United States
  • California Medical Research Associates, Inc. accepting new patients
    Northridge California 91324 United States
  • Valley Clinical Trials, Inc. accepting new patients
    Northridge California 91325 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • Havana Research Institute LLC completed
    Pasadena California 91105 United States
  • Miller Children's at Long Beach Medical Center accepting new patients
    Long Beach California 90806 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05757869
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 20000 study participants
Last Updated