The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
REACT-AF
REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
2 other identifiers
interventional
5,350
1 country
93
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Jul 2023
Longer than P75 for phase_3 atrial-fibrillation
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
April 9, 2026
April 1, 2026
6.1 years
April 19, 2023
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality.
The primary objective (efficacy objective) of the REACT-AF trial is to assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; and (3) All-cause mortality. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction; and classified as ischemic, hemorrhagic, or cause unknown based on CT or Magnetic Resonance (MR) scanning or autopsy. Systemic embolism is defined as an acute vascular occlusion of the extremities or any organ and must be documented by angiography, surgery, scintigraphy, or autopsy and require hospitalization. All-cause mortality will be defined as the underlying disease or injury that initiates the train of events resulting in death.
At 60 months
Secondary Outcomes (1)
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
At 60 months
Study Arms (2)
AFSW Guided DOAC
EXPERIMENTALAll participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
Continuous DOAC therapy
ACTIVE COMPARATORAll participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.
Interventions
The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.
Eligibility Criteria
You may qualify if:
- years of age.
- English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
- History of non-permanent atrial fibrillation.
- CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%.
- The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
- Willing and able to comply with the protocol, including:
- Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan
- Be willing to wear the smart watch for the suggested minimum of 14 hours a day
- Expected to be within cellular service range at least 80% of the time
- Willing and able to discontinue DOAC
- The participant is willing and able to provide informed consent.
You may not qualify if:
- Valvular or permanent atrial fibrillation.
- Current treatment with warfarin and unwilling or unable to take a DOAC.
- The participant is a woman who is pregnant or nursing.
- The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
- Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.
- Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
- Ablation for AF within the last 2 months.
- Prior or anticipated left atrial appendage occlusion or ligation.
- Mechanical prosthetic valve(s) or severe valve disease.
- Hypertrophic cardiomyopathy.
- Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
- Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion.
- The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
- The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
- The participant has a tremor on their ipsilateral side that the AFSW may be worn.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Northwestern Universitycollaborator
- Johns Hopkins Universitylead
Study Sites (93)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rod Passman
Northwestern University
- PRINCIPAL INVESTIGATOR
Dan Hanley
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Adjudication of safety events will be performed by a Clinical Endpoint Committee made up of blinded assessors. The Data Coordinating Center (DCC) blinded statistician(s) will also be blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2023
First Posted
May 1, 2023
Study Start
July 13, 2023
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
April 9, 2026
Record last verified: 2026-04