The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Start Date
7/13/2023
Completion Date
7/31/2029
Summary
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.
Detailed Description
REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center, investigational clinical trial of men and women aged 22-85 with a documented history of symptomatic or asymptomatic paroxysmal or persistent (AF) and a moderate risk of stroke measured by CHA2DS2-VASc score 1-4 for men, 2-4 for women (which stands for Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, age 65 to 74 and sex category (female)). Participants randomized to the experimental arm (on demand DOAC) will take the participants DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than1 hour) detected by the AFSW. Participants randomized to the standard of care (control) arm will remain on previously prescribed continuous DOAC throughout the study. A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices, with academic practices also enrolling from affiliated community sites. The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized. Up to 200 participants may be enrolled at any one site, and participation will last up to 60 months.
Eligibility Criteria
Age Range: 22 years to 85 years
Interventions
AFSW Guided DOAC
Continuous DOAC therapy
Conditions
Locations
Banner University
Phoenix, Arizona 85006
United States
University of Southern California - Keck School of Medicine
Los Angeles, California 90033
United States
University of California Los Angeles (UCLA Health)
Los Angeles, California 90095
United States
UC Davis Health
Sacramento, California 95817
United States
Scripps Health
San Diego, California 92103
United States
Kaiser Permanente
San Francisco, California 94115
United States
Stanford University
Stanford, California 94305
United States
University of Colorado
Aurora, Colorado 80045
United States
South Denver Cardiology Associates, P.C.
Littleton, Colorado 80120
United States
St. Elizabeth's Medical Center
Washington D.C., District of Columbia 20032
United States
Medical Faculty Associates George Washington University
Washington D.C., District of Columbia 20037
United States
BayCare Health Systems
Clearwater, Florida 33759
United States
University of Florida
Gainesville, Florida 32611
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
University of Miami - Leonard S. Miller SOM
Miami, Florida 33136
United States
Sarasota Memorial Health Care System
Sarasota, Florida 34236
United States
Cleveland Clinic Florida
Stuart, Florida 34994
United States
Baycare Health Systems Clearwater
Winter Haven, Florida 33881
United States
Emory University
Atlanta, Georgia 30332
United States
Georgia Arrhythmia Consultants and Research Institute
Warner Robins, Georgia 31093
United States
University of Illinois Chicago
Chicago, Illinois 60607
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Chicago
Chicago, Illinois 60637
United States
Loyola University Chicago
Chicago, Illinois 60660
United States
Alexian Brothers Health System
Elk Grove Village, Illinois 60007
United States
NorthShore University HealthSystem
Evanston, Illinois 60201
United States
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United States
Ascension St. Vincent
Indianapolis, Indiana 46260
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Maine Medical Partners MaineHealth Cardiology
Scarborough, Maine 04074
United States
Johns Hopkins Univeristy
Baltimore, Maryland 21218
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Mass General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
BMC - Brighton
Boston, Massachusetts 02135
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
UMass Chan Medical School
Worcester, Massachusetts 01655
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Corewell Health (Former Spectrum Health)
Grand Rapids, Michigan 49503
United States
Trinity Health Grand Rapids/Mercy Health
Grand Rapids, Michigan 49503
United States
William Beaumont Hospital
Royal Oak, Michigan 48073
United States
Trinity Health Michigan Heart - Ann Arbor
Ypsilanti, Michigan 48197
United States
Essentia Health The Duluth Clinic
Duluth, Minnesota 55812
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Hennepin Healthcare Research Institute
Minneapolis, Minnesota 55415
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
University Health Truman Medical Center
Kansas City, Missouri 64108
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey 08822
United States
Hackensack Meridian Health
Hackensack, New Jersey 07601
United States
Rutgers, the State University of New Jersey
Piscataway, New Jersey 08854
United States
The Valley Hospital, Inc.
Ridgewood, New Jersey 07450
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87102
United States
Presbyterian Healthcare Services
Albuquerque, New Mexico 87106
United States
University at Buffalo
Buffalo, New York 14214
United States
NYU Langone Health
New York, New York 10016
United States
Columbia University Medical Center
New York, New York 10032
United States
Weill Medical College of Cornell University
New York, New York 10065
United States
NewYork Presbyterian - Queens
Queens, New York 11355
United States
Staten Island University Hospital-Northwell Health
Staten Island, New York 10305
United States
Stony Brook University
Stony Brook, New York 11794
United States
Westchester Medical Center
Valhalla, New York 10595
United States
White Plains Hospital
White Plains, New York 10601
United States
University of North Carolina
Chapel Hill, North Carolina 27599
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
United States
Ohio State University Medical Center
Columbus, Ohio 43210
United States
OhioHealth Research Institute
Columbus, Ohio 43214
United States
Wooster Community Hospital
Wooster, Ohio 44691
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania 19301
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19144
United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212
United States
Penn State Health Medical Group Berks Cardiology
Wyomissing, Pennsylvania 19610
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
MUSC Health Heart and Vascular
Columbia, South Carolina 29204
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84112
United States
University of Virginia
Charlottesville, Virginia 22903
United States
James River Cardiology
Richmond, Virginia 23229
United States
Virginia Commonwealth University
Richmond, Virginia 23284
United States
St. Joseph Medical Center Tacoma
Tacoma, Washington 98405
United States
University of Wisconsin
Madison, Wisconsin 53706
United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin 53226
United States