This study is in progress, not accepting new patients

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 5403022, California 5332921 and other locations
Dates
study started
study ends 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, milvexian, apixaban, Counterfeit Drugs

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
    Torrance 5403022 California 5332921 90502 United States
  • Vitality Clinical Research
    Beverly Hills 5328041 California 5332921 90211 United States
  • Los Angeles Cardiology Associates
    Los Angeles 5368361 California 5332921 90017 United States
  • California Medical Research Associates, Inc.
    Northridge 5377985 California 5332921 91324 United States
  • Valley Clinical Trials, Inc.
    Northridge 5377985 California 5332921 91325 United States
  • University of Southern California
    Los Angeles 5368361 California 5332921 90033 United States
  • Havana Research Institute LLC
    Pasadena 5381396 California 5332921 91105 United States
  • Miller Children's at Long Beach Medical Center
    Long Beach 5367929 California 5332921 90806 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05757869
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 20296 people participating
Last Updated