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L'évaluation du rythme pour l'anticoagulation avec surveillance continue de la fibrillation auriculaire (REACT-AF)

2 novembre 2026 mis à jour par: Johns Hopkins University

REACT-AF : évaluation du rythme pour l'anticoagulation avec surveillance continue de la fibrillation auriculaire

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

5350

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Arizona
    • California
      • Los Angeles, California, États-Unis, 90033
      • Los Angeles, California, États-Unis, 90095
        • Recrutement
        • University of California Los Angeles (UCLA Health)
        • Contact:
        • Chercheur principal:
          • David Cho, MD
      • Sacramento, California, États-Unis, 95817
      • San Diego, California, États-Unis, 92103
      • San Francisco, California, États-Unis, 94115
      • Stanford, California, États-Unis, 94305
        • Recrutement
        • Stanford University
        • Chercheur principal:
          • Alexander Perino
        • Contact:
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Recrutement
        • University of Colorado
        • Contact:
        • Chercheur principal:
          • Amar Trivedi
      • Littleton, Colorado, États-Unis, 80120
        • Recrutement
        • South Denver Cardiology Associates, P.C.
        • Chercheur principal:
          • Srikanth Sundaram
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20037
        • Retiré
        • Medical Faculty Associates George Washington University
    • Florida
      • Clearwater, Florida, États-Unis, 33759
        • Recrutement
        • BayCare Health Systems
        • Contact:
        • Chercheur principal:
          • Shalin Shah
      • Gainesville, Florida, États-Unis, 32611
      • Jacksonville, Florida, États-Unis, 32224
        • Recrutement
        • Mayo Clinic
        • Chercheur principal:
          • Andrew Tseng, MD
        • Contact:
      • Miami, Florida, États-Unis, 33136
        • Recrutement
        • University of Miami - Leonard S. Miller SOM
        • Contact:
        • Chercheur principal:
          • Alex Velasquez, MD
      • Sarasota, Florida, États-Unis, 34236
        • Actif, ne recrute pas
        • Sarasota Memorial Health Care System
      • Stuart, Florida, États-Unis, 34994
        • Retiré
        • Cleveland Clinic Florida
      • Winter Haven, Florida, États-Unis, 33881
        • Recrutement
        • Baycare Health Systems Clearwater
        • Contact:
        • Chercheur principal:
          • Rodrigo Bolanos, MD
    • Georgia
      • Atlanta, Georgia, États-Unis, 30332
        • Recrutement
        • Emory University
        • Contact:
        • Contact:
          • Jovita Brevard
          • Numéro de téléphone: jovita.johnson@emory.edu
        • Chercheur principal:
          • Michael Lloyd
      • Warner Robins, Georgia, États-Unis, 31093
        • Recrutement
        • Georgia Arrhythmia Consultants and Research Institute
        • Chercheur principal:
          • Feliz Sogade, MD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
      • Chicago, Illinois, États-Unis, 60637
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern University
        • Chercheur principal:
          • Bradley Knight
        • Contact:
      • Chicago, Illinois, États-Unis, 60660
        • Recrutement
        • Loyola University Chicago
        • Contact:
        • Chercheur principal:
          • Peter Santucci, MD
      • Chicago, Illinois, États-Unis, 60607
        • Recrutement
        • University of Illinois Chicago
        • Chercheur principal:
          • David Sanders
        • Contact:
      • Elk Grove Village, Illinois, États-Unis, 60007
      • Evanston, Illinois, États-Unis, 60201
        • Recrutement
        • NorthShore University HealthSystem
        • Contact:
        • Chercheur principal:
          • Jeremiah Wasserlauf, MD
      • Naperville, Illinois, États-Unis, 60540
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46260
    • Iowa
      • Iowa City, Iowa, États-Unis, 52242
        • Recrutement
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Chercheur principal:
          • Peter Farjo
    • Maine
      • Scarborough, Maine, États-Unis, 04074
        • Recrutement
        • Maine Medical Partners MaineHealth Cardiology
        • Chercheur principal:
          • Jordan Leyton-Mange, MD
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, États-Unis, 21218
        • Recrutement
        • Johns Hopkins University
        • Contact:
        • Chercheur principal:
          • Hugh Calkins
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Contact:
        • Chercheur principal:
          • Peter Zimetbaum, MD
      • Boston, Massachusetts, États-Unis, 02118
        • Recrutement
        • Boston Medical Center
        • Contact:
        • Chercheur principal:
          • Robert Helm
      • Boston, Massachusetts, États-Unis, 02111
      • Boston, Massachusetts, États-Unis, 02135
        • Recrutement
        • St. Elizabeth's Medical Center
        • Contact:
        • Chercheur principal:
          • John Wylie
      • Boston, Massachusetts, États-Unis, 02114
        • Recrutement
        • Mass General Hospital
        • Contact:
        • Chercheur principal:
          • Eugene Chung
      • Boston, Massachusetts, États-Unis, 02135
        • Recrutement
        • BMC - Brighton
        • Chercheur principal:
          • Alena Goldman, MD
        • Contact:
      • Burlington, Massachusetts, États-Unis, 01805
        • Recrutement
        • Lahey Hospital & Medical Center
        • Contact:
        • Chercheur principal:
          • Matthew Reynolds
      • Worcester, Massachusetts, États-Unis, 01655
        • Actif, ne recrute pas
        • UMass Chan Medical School
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Recrutement
        • Henry Ford Health
        • Contact:
        • Chercheur principal:
          • Marc Lahiri
        • Contact:
      • Grand Rapids, Michigan, États-Unis, 49503
      • Grand Rapids, Michigan, États-Unis, 49503
        • Recrutement
        • Trinity Health Grand Rapids/Mercy Health
        • Chercheur principal:
          • Muhammad Farooq, MD
        • Contact:
      • Royal Oak, Michigan, États-Unis, 48073
        • Recrutement
        • William Beaumont Hospital
        • Chercheur principal:
          • Nishaki Mehta
        • Contact:
      • Ypsilanti, Michigan, États-Unis, 48197
        • Recrutement
        • Trinity Health Michigan Heart - Ann Arbor
        • Contact:
        • Chercheur principal:
          • Mohammad-Ali Jazayeri
    • Minnesota
      • Duluth, Minnesota, États-Unis, 55812
        • Actif, ne recrute pas
        • Essentia Health The Duluth Clinic
      • Minneapolis, Minnesota, États-Unis, 55455
        • Recrutement
        • University of Minnesota
        • Chercheur principal:
          • Lin Yee Chen, MD
        • Contact:
      • Minneapolis, Minnesota, États-Unis, 55415
        • Recrutement
        • Hennepin Healthcare Research Institute
        • Chercheur principal:
          • Gautam Shroff, MD
        • Contact:
      • Minneapolis, Minnesota, États-Unis, 55407
        • Recrutement
        • Minneapolis Heart Institute Foundation
        • Chercheur principal:
          • John Zakaib
        • Contact:
        • Contact:
    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • Retiré
        • University Health Truman Medical Center
      • St Louis, Missouri, États-Unis, 63110
    • New Jersey
      • Flemington, New Jersey, États-Unis, 08822
        • Recrutement
        • Advanced Heart and Vascular Institute of Hunterdon
        • Chercheur principal:
          • Andrey Espinoza, MD
        • Contact:
        • Contact:
      • Hackensack, New Jersey, États-Unis, 07601
        • Recrutement
        • Hackensack Meridian Health
        • Chercheur principal:
          • Taya Glotzer, MD
        • Contact:
          • Jennifer Baxter
          • Numéro de téléphone: (551)996-3775
        • Contact:
      • Piscataway, New Jersey, États-Unis, 08854
        • Recrutement
        • Rutgers, the State University of New Jersey
        • Chercheur principal:
          • Partho Sengupta
        • Contact:
      • Ridgewood, New Jersey, États-Unis, 07450
        • Recrutement
        • The Valley Hospital, Inc.
        • Chercheur principal:
          • Suneet Mittal
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87102
      • Albuquerque, New Mexico, États-Unis, 87106
        • Actif, ne recrute pas
        • Presbyterian Healthcare Services
    • New York
      • Buffalo, New York, États-Unis, 14214
        • Recrutement
        • University at Buffalo
        • Contact:
        • Chercheur principal:
          • James Russell, DO
      • New York, New York, États-Unis, 10016
        • Recrutement
        • NYU Langone Health
        • Chercheur principal:
          • Joseph Germano, MD
        • Contact:
      • New York, New York, États-Unis, 10032
        • Recrutement
        • Columbia University Medical Center
        • Chercheur principal:
          • Angelo Biviano
        • Contact:
      • New York, New York, États-Unis, 10065
        • Recrutement
        • Weill Medical College of Cornell University
        • Contact:
        • Chercheur principal:
          • Jim Cheung, MD
        • Contact:
          • Penn Collins
          • Numéro de téléphone: gpc4001@med.cornell.edu
      • Queens, New York, États-Unis, 11355
        • Recrutement
        • NewYork Presbyterian - Queens
        • Contact:
        • Chercheur principal:
          • Joon Hyuk Kim
      • Staten Island, New York, États-Unis, 10305
        • Recrutement
        • Staten Island University Hospital-Northwell Health
        • Contact:
        • Chercheur principal:
          • Rina Shah, MD
      • Stony Brook, New York, États-Unis, 11794
      • Valhalla, New York, États-Unis, 10595
      • White Plains, New York, États-Unis, 10601
        • Recrutement
        • White Plains Hospital
        • Contact:
        • Chercheur principal:
          • James Peacock
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27599
        • Recrutement
        • University of North Carolina
        • Chercheur principal:
          • Anil Gehi, MD
        • Contact:
      • Winston-Salem, North Carolina, États-Unis, 27157
    • Ohio
      • Cincinnati, Ohio, États-Unis, 45267
        • Recrutement
        • University of Cincinnati College of Medicine
        • Chercheur principal:
          • Richard Becker
        • Contact:
      • Cincinnati, Ohio, États-Unis, 45219
        • Recrutement
        • The Lindner Center for Research and Education at The Christ Hospital
        • Chercheur principal:
          • Daniel Pelchovitz, MD
        • Contact:
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • Ohio State University Medical Center
        • Chercheur principal:
          • Salvatore Savona, MD
        • Contact:
        • Contact:
      • Columbus, Ohio, États-Unis, 43214
        • Recrutement
        • OhioHealth Research Institute
        • Contact:
        • Chercheur principal:
          • Eugene Fu, MD
      • Wooster, Ohio, États-Unis, 44691
        • Recrutement
        • Wooster Community Hospital
        • Contact:
        • Chercheur principal:
          • Cyril Ofori, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • University of Oklahoma Health Sciences Center
        • Chercheur principal:
          • Stavros Stavrakis, MD
        • Contact:
    • Pennsylvania
      • Paoli, Pennsylvania, États-Unis, 19301
        • Pas encore de recrutement
        • Cardiology Consultants of Philadelphia
        • Contact:
        • Chercheur principal:
          • Colin Movsowitz, MD
      • Philadelphia, Pennsylvania, États-Unis, 19144
        • Recrutement
        • Thomas Jefferson University
        • Chercheur principal:
          • Daniel Frisch, MD
        • Contact:
      • Pittsburgh, Pennsylvania, États-Unis, 15212
        • Recrutement
        • Allegheny Singer Research Institute
        • Contact:
        • Chercheur principal:
          • Amit Thosani
        • Contact:
      • Wyomissing, Pennsylvania, États-Unis, 19610
        • Recrutement
        • Penn State Health Medical Group Berks Cardiology
        • Contact:
        • Chercheur principal:
          • Ronald Polinsky, MD
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Recrutement
        • Rhode Island Hospital
        • Chercheur principal:
          • Estelle Torbey, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Recrutement
        • Medical University of South Carolina
        • Chercheur principal:
          • Rachel Kaplan
        • Contact:
      • Columbia, South Carolina, États-Unis, 29204
        • Recrutement
        • MUSC Health Heart and Vascular
        • Contact:
          • Jacqueline Sheriod-Scott
          • Numéro de téléphone: 803-254-3278
          • E-mail: sheriods@musc.edu
        • Chercheur principal:
          • Venkateshwar Gottipaty, MD
    • Texas
      • Austin, Texas, États-Unis, 78705
        • Recrutement
        • Texas Cardiac Arrhythmia Research Foundation
        • Contact:
        • Chercheur principal:
          • Amin Al Ahmad
      • Dallas, Texas, États-Unis, 75390
        • Recrutement
        • University of Texas Southwestern Medical Center
        • Contact:
        • Chercheur principal:
          • Mark Link, MD
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • Baylor College of Medicine
        • Chercheur principal:
          • Mihail Chelu, MD
        • Contact:
          • Stephen Harold
          • Numéro de téléphone: 713-798-7227
          • E-mail: harold@bcm.edu
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • Houston Methodist Hospital
        • Chercheur principal:
          • Miguel Valderrabano, MD
        • Contact:
      • Houston, Texas, États-Unis, 77030
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Recrutement
        • University of Utah
        • Contact:
        • Chercheur principal:
          • Marc Engels, MD
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22903
        • Recrutement
        • University of Virginia
        • Chercheur principal:
          • Rohit Malhotra
        • Contact:
      • Richmond, Virginia, États-Unis, 23284
        • Recrutement
        • Virginia Commonwealth University
        • Chercheur principal:
          • Kenneth Ellenbogen
        • Contact:
      • Richmond, Virginia, États-Unis, 23229
        • Recrutement
        • James River Cardiology
        • Chercheur principal:
          • Shaival Kapadia, MD
        • Contact:
    • Washington
      • Tacoma, Washington, États-Unis, 98405
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53706
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Recrutement
        • Medical College of Wisconsin Froedtert Hospital
        • Contact:
        • Chercheur principal:
          • Jason Rubenstein

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

22 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. 22-85 years of age.

  2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.

  3. History of non-permanent atrial fibrillation.

  4. 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%.

  5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.

  6. 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

  7. Willing and able to discontinue DOAC

  8. The participant is willing and able to provide informed consent.

Exclusion Criteria:

  1. Valvular or permanent atrial fibrillation.

  2. Current treatment with warfarin and unwilling or unable to take a DOAC.

  3. The participant is a woman who is pregnant or nursing.

  4. 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.

  5. 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.

  6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.

  7. Any documented single AF episode lasting ≥ 1 hour on a cardiac monitor performed within 90 days prior to randomization.

  8. Ablation for AF within the last 2 months.

  9. Prior or anticipated left atrial appendage occlusion or ligation.

  10. Mechanical prosthetic valve(s) or severe valve disease.

  11. Hypertrophic cardiomyopathy.

  12. 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).

  13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator's discretion.

  14. 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.

  15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.

  16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.

  17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).

  18. Known hypersensitivity or contraindication to direct oral anticoagulants.

  19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.

  20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.

  21. > 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.

  22. 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)

  23. Stage 4 or 5 chronic kidney disease.

  24. 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: AFSW Guided DOAC

All 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.
Dispositif: AFSW Guided DOAC

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.

Autres noms:
  • Montre Apple
Comparateur actif: Continuous DOAC therapy

All 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.
Médicament: Continuous DOAC therapy

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

Autres noms:
  • Thérapie d'anticoagulation orale

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: At 60 months

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
Délai: At 60 months

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.
At 60 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Johns Hopkins University

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)
Northwestern University

Les enquêteurs

  • Chercheur principal: Rod Passman, Northwestern University
  • Chercheur principal: Dan Hanley, Johns Hopkins University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 juillet 2023

Achèvement primaire (Estimé)

31 juillet 2029

Achèvement de l'étude (Estimé)

31 juillet 2029

Dates d'inscription aux études

Première soumission

19 avril 2023

Première soumission répondant aux critères de contrôle qualité

19 avril 2023

Première publication (Réel)

1 mai 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB00354588
  • 1U24HL165066-01 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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