AzTrials
AzTrials

Atrial FibrillationPhase 3REACT-AFNCT05836987

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

A Phase 3 study testing AFSW Guided DOAC and Continuous DOAC therapy in people with Atrial Fibrillation, run by Johns Hopkins University at 93 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
AFSW Guided DOAC and Continuous DOAC therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,350 participants
Where
93 sitesUnited States
Study dates
13 Jul 2023to 31 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22-85 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 1-5 for men and 2-5 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:
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  • 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.

Who cannot join

  • 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 daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration. Use of low-dose aspirin is permitted.
  • 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.
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  • Any documented single AF episode lasting ≥ 1 hour on a cardiac monitor performed within 90 days prior to randomization.
  • 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.
  • Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
  • Known hypersensitivity or contraindication to direct oral anticoagulants.
  • Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
  • Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
  • > 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
  • History of ECG-documented, sustained atrial flutter that has not been treated with ablation (participants with atrial flutter who have been ablated are eligible for enrollment)
  • Stage 4 or 5 chronic kidney disease.
  • Conditions associated with an increased risk of bleeding:
  • Major surgery in the previous month
  • Planned surgery or intervention in the next three months that would require cessation of anticoagulation > 2 weeks.
  • History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding
  • Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
  • Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
  • Hemorrhagic disorder or bleeding diathesis
  • Need for anticoagulant treatment for disorders other than AF
  • Uncontrolled hypertension (Systolic Blood Pressure >180 mmHg and/or Diastolic Blood Pressure >100 mmHg)

Trial locations and contacts

93 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shea Smith contact

sgluhm@stanford.edu

93 sites in 1 country

United States93 sites, 86 recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

    Elvia Padilla, EPadillaMendez@salud.unm.edu

    Noela Garcia-Soberanez, NGarciaSoberanez@salud.unm.edu

    Recruiting

  • Presbyterian Healthcare Services

    Albuquerque, New Mexico, 87106

    Active, not recruiting

  • Emory University

    Atlanta, Georgia, 30332

    Thomas Preiser, tpreise@emory.edu

    Jovita Brevard, jovita.johnson@emory.edu

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Megan Collett, 970-624-1581, megan.collett@uchealth.org

    Amar Trivedi

    Recruiting

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

    Deb Cardinal, 512-431-4868, dscardinal@austinheartbeat.com

    Amin Al Ahmad

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Michele Martucci, 410-502-0517, mmill148@jhmi.edu

    Rahma Semma, 223-533-4043, nhorstm3@jhu.edu

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Juan Carlos Collado Falcon, Juan.Carlos.Collado.Falcon@tuftsmedicine.org

    Abena Adwetewa-Badu, Abena.Adwetewa-Badu@tuftsmedicine.org

    Recruiting

  • Mass General Hospital

    Boston, Massachusetts, 02114

    Kristen Steinmetz, 781-424-7184, ksteinmetz@mgh.harvard.edu

    Eugene Chung

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Daniela Hincapie Tabres, dhincapietabares@bwh.harvard.edu

    Obadah Aloum, OALOUM@BWH.HARVARD.EDU

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Laura Gavrilles, 617-638-8718, laura.gavrilles@bmc.org

    Robert Helm

    Recruiting

  • BMC - Brighton

    Boston, Massachusetts, 02135

    Kemberlie Adolphe, 339-208-9891, Kemberlie.Adolphe@bmc.org

    Alena Goldman, MD

    Recruiting

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

    Rina Vaquerano, 617-789-2023, rina.vaquerano@steward.org

    John Wylie

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Jenifer M Kaufman, 617-632-8956, jmkaufma@bidmc.harvard.edu

    Patricia Tyler, (617) 632-7727, ptyler@bidmc.harvard.edu

    Recruiting

  • University at Buffalo

    Buffalo, New York, 14214

    Cassandra Davern, 716-881-8299, cadavern@buffalo.edu

    James Russell, DO

    Recruiting

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

    Jean Byrne, 781-744-1901, jean.byrne@lahey.org

    Matthew Reynolds

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Elias Wen, 919-843-5219, elias_wen@med.unc.edu

    Anil Gehi, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Krista Szymanski, 843-876-6846, szymankr@musc.edu

    Rachel Kaplan

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Sophie Henning, 434-710-7717, SEH2NX@uvahealth.org

    Rohit Malhotra

    Recruiting

  • University of Illinois Chicago

    Chicago, Illinois, 60607

    David Sanders, MD, djsand13@uic.edu

    David Sanders

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    CTU Regulatory Team, cturegulatoryteam@nm.org

    Bradley Knight

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Nusrat Jahan, 312-942-1630, nusrat_jahan@rush.edu

    Christine Radochonski, Christine_Radochonski@rush.edu

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Shahram Sarrafi, ssarrafi1@uchicagomedicine.org

    Kie Ng, kie@bsd.uchicago.edu

    Recruiting

  • Loyola University Chicago

    Chicago, Illinois, 60660

    Nancy Schoenecker, 708-216-2646, nschoenecker@luc.edu

    Peter Santucci, MD

    Recruiting

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

    Anne Voorhorst, 513-585-1777, anne.voorhorst@thechristhospital.com

    Daniel Pelchovitz, MD

    Recruiting

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

    Harshada More, 513-558-4739, morehp@ucmail.uc.edu

    Richard Becker

    Recruiting

  • BayCare Health Systems

    Clearwater, Florida, 33759

    Karen Herring, 813-875-9000 ext. 280209, karen.herring@baycare.org

    Shalin Shah

    Recruiting

  • MUSC Health Heart and Vascular

    Columbia, South Carolina, 29204

    Jacqueline Sheriod-Scott, 803-254-3278, sheriods@musc.edu

    Venkateshwar Gottipaty, MD

    Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

    Adrianne Miller, 614-688-8252, adrianne.miller3@osumc.edu

    Ashley Thomas, 614-366-8650, ashley.thomas@osumc.edu

    Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

    Reem Bekheet, 937-218-3542, reem.bekheet@ohiohealth.com

    Eugene Fu, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Vukile Mlambo, 214-648-3112, vukile.mlambo@utsouthwestern.edu

    Mark Link, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Briita Wanhala, 313-916-9575, bwanhal1@hfhs.org

    Madelyn Fabry, 313-916-1719, mfabry1@hfhs.org

    Recruiting

  • Essentia Health The Duluth Clinic

    Duluth, Minnesota, 55812

    Active, not recruiting

  • Alexian Brothers Health System

    Elk Grove Village, Illinois, 60007

    Michelle Garcia, michelle.garcia5@ascension.org

    Jeanine Pilat, jeanine.pilat@ascension.org

    Recruiting

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

    Marisa Durante, 847-570-2125, mdurante@northshore.org

    Jeremiah Wasserlauf, MD

    Recruiting

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey, 08822

    Alexis Bellafiore, 908-291-3405, abellafiore@ahvi-nj.com

    Jessica Senatore, jsenatore@ahvi-nj.com

    Recruiting

  • University of Florida

    Gainesville, Florida, 32611

    Walter Erikson, erikson.walter@medicine.ufl.edu

    Vanessa Scheuble, vanessa.scheuble@medicine.ufl.edu

    Recruiting

  • Corewell Health (Former Spectrum Health)

    Grand Rapids, Michigan, 49503

    Lisa Van Loo, 616-391-3327, lisa.vanloo@spectrumhealth.org

    Jose Gavina, jose.gavina@corewellhealth.org

    Recruiting

  • Trinity Health Grand Rapids/Mercy Health

    Grand Rapids, Michigan, 49503

    Melissa Brown-Culbertson, 616-685-6326, melissa.brown-culbertson@trinity-health.org

    Muhammad Farooq, MD

    Recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Jennifer Baxter, 551-996-3775, jennifer.baxter@hmhn.org

    Jennifer Baxter, (551)996-3775

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Stephen Harold, 713-798-7227, harold@bcm.edu

    Mihail Chelu, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Chinwe Ngumezi, 346-238-0290, ccngumezi@houstonmethodist.org

    Miguel Valderrabano, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Mary Pierce, mary.h.pierce@uth.tmc.edu

    Vickie Ramirez, vickie.m.ramirez@uth.tmc.edu

    Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

    Regina Margiotti, 317-583-6151, regina.margiotti@ascension.org

    Ann Renick, (317) 338-6152, anne.renick@ascension.org

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Trisha Elliott, 319-384-1628, trisha-elliott@uiowa.edu

    Peter Farjo

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Jessica Murphey, 904-953-4512, Murphey.Jessica@mayo.edu

    Andrew Tseng, MD

    Recruiting

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

    Withdrawn

  • South Denver Cardiology Associates, P.C.

    Littleton, Colorado, 80120

    Kathrin Siegel, 303-703-2053, ksiegel@southdenver.com

    Srikanth Sundaram

    Recruiting

  • University of Southern California - Keck School of Medicine

    Los Angeles, California, 90033

    Rohit Varma, RohitVarma.Penmetsa@med.usc.edu

    Stephanie Chao, (323) 442-0750, Stephanie.Chao@med.usc.edu

    Recruiting

  • University of California Los Angeles (UCLA Health)

    Los Angeles, California, 90095

    Monserrath Campos, monserrathcampos@mednet.ucla.edu

    David Cho, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53706

    Karen Olson, kjolson@medicine.wisc.edu

    Nicole Mildenstein, 608-262-3653, mildenstein@medicine.wisc.edu

    Recruiting

  • University of Miami - Leonard S. Miller SOM

    Miami, Florida, 33136

    Carmen Maria Baez-Garcia, 305-243-3845, cbaezgarcia@med.miami.edu

    Alex Velasquez, MD

    Recruiting

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Debbi Hoff, dhoff@mcw.edu

    Jason Rubenstein

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Andrew Garner, 612-863-3818, andrew.garner@allina.com

    Julianne Feola, 612-683-6066, julianne.feola@allina.com

    Recruiting

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota, 55415

    Sahil Thummar, sthummar@bermancenter.org

    Gautam Shroff, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Maddy Chopp, 612-626-7041, Chopp015@umn.edu

    Lin Yee Chen, MD

    Recruiting

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540

    Josilyn Klimek, Josilyn.Klimek@midwestcardio.com

    Moeen Saleem

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Mollie Machado, 516-663-8638, mollie.machado@nyulangone.org

    Joseph Germano, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Raghd Ahmed, 347-400-9812, ria2120@cumc.columbia.edu

    Angelo Biviano

    Recruiting

  • Weill Medical College of Cornell University

    New York, New York, 10065

    Dolores Reynolds, 212-746-4617, dtr2001@med.cornell.edu

    Penn Collins, gpc4001@med.cornell.edu

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Stephan Biheng, Stephan-Biheng@ou.edu

    Stavros Stavrakis, MD

    Recruiting

  • Cardiology Consultants of Philadelphia

    Paoli, Pennsylvania, 19301

    Hope Bernhardy, 267-479-5325, hopeb@ccpdocs.com

    Colin Movsowitz, MD

    Not yet recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144

    Ashley Borgella, 267-226-8085, ashley.borgella@jefferson.edu

    Daniel Frisch, MD

    Recruiting

  • Banner University

    Phoenix, Arizona, 85006

    Herisse Sabulao, herisse.sabulao@bannerhealth.com

    Raeven Maxwell, raeven.maxwell@bannerhealth.com

    Recruiting

  • Rutgers, the State University of New Jersey

    Piscataway, New Jersey, 08854

    Glaucia Dos Santos-Vaccaro, 732-235-6117, gd301@rwjms.rutgers.edu

    Partho Sengupta

    Recruiting

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

    Caitlin Phalunas, 412-359-3747, caitlin.phalunas@ahn.org

    Summer Ballou, 412-359-5281, Summer.Ballou@ahn.org

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Kelly Franchetti, 401-444-9828, kfranchetti@brownhealth.org

    Estelle Torbey, MD

    Recruiting

  • NewYork Presbyterian - Queens

    Queens, New York, 11355

    Jackson Ng, 718-607-2944, jan9044@nyp.org

    Joon Hyuk Kim

    Recruiting

  • James River Cardiology

    Richmond, Virginia, 23229

    Morgan Hamilton, 540-244-1552, morgan.hamilton@alignedcardio.com

    Shaival Kapadia, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

    Anya Baranova, Anna.Baranova2@vcuhealth.org

    Kenneth Ellenbogen

    Recruiting

  • The Valley Hospital, Inc.

    Ridgewood, New Jersey, 07450

    RoseMarie Hroncich, 201-447-8453, rhronci@valleyhealth.com

    Suneet Mittal

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

    Trevia Butler, 248-551-5471, Trevia.Butler@corewellhealth.org

    Nishaki Mehta

    Recruiting

  • UC Davis Health

    Sacramento, California, 95817

    Edward Lingayo, lingayo@health.ucdavis.edu

    Uma Srivatsa

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Andy Rivera, 801-213-4099, andy.rivera@hsc.utah.edu

    Marc Engels, MD

    Recruiting

  • Scripps Health

    San Diego, California, 92103

    Janet Lawrence, Lawrence.Janet@scrippshealth.org

    Evan Muse

    Recruiting

  • Kaiser Permanente

    San Francisco, California, 94115

    Annie Lei, Annie.X.Lei@kp.org

    Quyen Chau, Quyen.X.Chau@kp.org

    Not yet recruiting

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34236

    Active, not recruiting

  • Maine Medical Partners MaineHealth Cardiology

    Scarborough, Maine, 04074

    Hilary Curtis, 207-303-1571, hilary.curtis@mainehealth.org

    Brenda Galsgow, (207) 303-1304, brenda.glasgow@mainehealth.org

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Kyle Smith, kyle.smith1@wustl.edu

    Sharon Heuerman, sheuerman@wustl.edu

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Diona Gjermeni, MD, 650-333-9228, gjermeni@stanford.edu

    Alexander Perino

    Recruiting

  • Staten Island University Hospital-Northwell Health

    Staten Island, New York, 10305

    Alexandra Pantea, 718-226-6438, apantea@northwell.edu

    Rina Shah, MD

    Recruiting

  • Stony Brook University

    Stony Brook, New York, 11794

    Melanie Rooney, 631-444-6967, melanie.rooney@stonybrookmedicine.edu

    Michelle Xikis, Michele.xikis@stonybrookmedicine.edu

    Recruiting

  • Cleveland Clinic Florida

    Stuart, Florida, 34994

    Withdrawn

  • St. Joseph Medical Center Tacoma

    Tacoma, Washington, 98405

    Boyoung Moore, boyoung.moore@commonspirit.org

    Nasir Shariff

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Allyson Pulsoni, allyson.pulsoni@wmchealth.org

    Erida Castro-Rivas, Erida.Castro@wmchealth.org

    Recruiting

  • Georgia Arrhythmia Consultants and Research Institute

    Warner Robins, Georgia, 31093

    Gbenga Adeyinka, 478-607-2469, Gadeyinka@gacri.com

    Abbey McGlashan, 478-607-2469, amcglashan@gacri.com

    Recruiting

  • Medical Faculty Associates George Washington University

    Washington D.C., District of Columbia, 20037

    Withdrawn

  • White Plains Hospital

    White Plains, New York, 10601

    Aileen Ferrick, 914-849-2690, aferrick@wphospital.org

    Uloma Ijomah, (914) 849-2690, uijomah@wphospital.org

    Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

    Kimberly Combs, Kimberly.Combs@Advocatehealth.org

    Tarek Zaho, MD, (336) 713-7024, Tarek.Zaho@Advocatehealth.org

    Recruiting

  • Baycare Health Systems Clearwater

    Winter Haven, Florida, 33881

    Amanda Steadham, 863-293-1121 ext. 201409, Amanda.Steadham@baycare.org

    Rodrigo Bolanos, MD

    Recruiting

  • Wooster Community Hospital

    Wooster, Ohio, 44691

    Erica Stahl, 330-263-8359, estahl@wchosp.org

    Cyril Ofori, MD

    Recruiting

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655

    Active, not recruiting

  • Penn State Health Medical Group Berks Cardiology

    Wyomissing, Pennsylvania, 19610

    Emese Futchko, 610-685-8500, efutchko@pennstatehealth.psu.edu

    Ronald Polinsky, MD

    Recruiting

  • Trinity Health Michigan Heart - Ann Arbor

    Ypsilanti, Michigan, 48197

    Autumn Howe, ahowe@michiganheart.com

    Mohammad-Ali Jazayeri

    Recruiting

Other trials in United States

About this study

Official title: REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

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.

Read the 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 1-5 for men, 2-5 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.

Being tested
AFSW Guided DOAC, Continuous DOAC therapy
Keywords
Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism
Medical subject headings
Atrial Fibrillation, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFSW Guided DOACDevice

    Also called Apple Watch

    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 therapyDrug

    Also called Oral Anticoagulation therapy

    DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

Study groups in NCT05836987
Study groupRoleWhat they receive
AFSW Guided DOACExperimentalAll 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.
Receives: Device: AFSW Guided DOAC
Continuous DOAC therapyActive 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.
Receives: Drug: Continuous DOAC therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 60 months

Secondary outcomes (1)

  1. To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.

    Oral anticoagulation carries a risk of major bleeding, including life-threatening hemorrhage, the intervention is expected to reduce the safety endpoint, major bleeding, by > 35%, and the study is powered for the superiority of the safety endpoint.

    Major bleeding will be defined as requiring hospitalization and by ≥1 of the following International Society on Thrombosis and Haemostasis (ISTH) criteria: (1) Bleeding associated with a reduction in hemoglobin level of at least 2.0 g/dL; (2) Bleeding leading to transfusion of at least two units of blood or packed cells; or (3) Symptomatic bleeding in a critical area or organ such as intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding.

    Measured: At 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start13 Jul 2023
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants randomized (1:1) to the experimental arm (AFSW-guided DOAC) will only take DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than 1 hour) detected by the participants AFSW if no further AF is detected. Participants randomized to the standard of care arm will remain on continuous DOAC throughout the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836987
Sponsor's protocol ID
IRB00354588
Other IDs
1U24HL165066-01
Acronym
REACT-AF
Status last verified
Nov 2026
First submitted
19 Apr 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AFSW Guided DOAC and Continuous DOAC therapy in people with Atrial Fibrillation, run by Johns Hopkins University at 93 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shea Smith (sgluhm@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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