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A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

NCT05757869

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Atrial Fibrillation

Interventions: Milvexian, Apixaban, Placebo, Apixaban Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1052)
  • Alexander City, Alabama, United States
  • Birmingham, Alabama, United States
  • Dothan, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Scottsdale, Arizona, United States
  • Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Beverly Hills, California, United States
  • Chula Vista, California, United States
  • Chula Vista, California, United States
  • Fremont, California, United States
  • Glendora, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Merced, California, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • Northridge, California, United States
  • Palm Springs, California, United States
  • Pasadena, California, United States
  • Rancho Mirage, California, United States
  • Redwood City, California, United States
  • San Diego, California, United States
  • + 1022 more on CT.gov