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A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Sponsor: Janssen Research & Development, LLC
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20284
Start Date
2023-04-11
Completion Date
2026-12-08
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1052)
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
Merced Vein and Vascular Center
Merced, California, United States
Radin Cardiovascular Medical Group
Newport Beach, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Health Care
Palm Springs, California, United States
Havana Research Institute LLC
Pasadena, California, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States
Stanford Health Care
Redwood City, California, United States
San Diego Cardiac Center
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Ramin Manshadi, MD
Stockton, California, United States
UCLA School of Medicine
Torrance, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
North County Internal Medicine
Vista, California, United States
John Muir Physician Network Clin. Research Center
Walnut Creek, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Aurora Denver Cardiology Associates 1
Denver, Colorado, United States
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Western Connecticut Health Network/Danbury Hospital
Danbury, Connecticut, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
PriMed Physicians, A Member of NE Medical Group
Trumbull, Connecticut, United States
Cardiology Physicians
Newark, Delaware, United States
George Washington University School of Medicine
Washington D.C., District of Columbia, United States
Orlando Heart Specialists
Altamonte Springs, Florida, United States
Bay Area Cardiology Associates, P.A. - Brandon Office
Brandon, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Cardiology Consultants
Daytona Beach, Florida, United States
Cardiology Associates Research Company
Daytona Beach, Florida, United States
Accel Research Sites
DeLand, Florida, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Watson Clinic
Lakeland, Florida, United States
Clearwater Cardiovascular Consultants 1
Largo, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Reliant Medical Research
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Ascension Sacred Heart Hospital
Miramar Beach, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Central Florida Medical Associates
Orange City, Florida, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States
Cardiology Consultants 1
Pensacola, Florida, United States
North Broward Hospital District
Pompano Beach, Florida, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States
Coastal Cardiology Consultants
Safety Harbor, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Adtremed Inc
Tampa, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
Helping Hands Health Center dba Helping Hands Evolution Research
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute 1
Wellington, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Piedmont Heart Institute 1
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Atlanta Heart Specialists
Cumming, Georgia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
Cardiology Consultants of South Georgia Inc
Thomasville, Georgia, United States
The Queens Medical Center
Honolulu, Hawaii, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Clinical Investigation Specialists
Gurnee, Illinois, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Prairie Education And Research Cooperative
O'Fallon, Illinois, United States
Advocate Heart Institute
Oak Lawn, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Blessing Hospital
Quincy, Illinois, United States
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, United States
Springfield Clinic 1st
Springfield, Illinois, United States
Bloomington Hospital
Bloomington, Indiana, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
St. Elizabeth Physicians
Crittenden, Kentucky, United States