Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Avaliação do Ritmo para Anticoagulação com Monitoramento Contínuo da Fibrilação Atrial (REACT-AF)

2 de novembro de 2026 atualizado por: Johns Hopkins University

REACT-AF: Avaliação do Ritmo para Anticoagulação com Monitorização Contínua da Fibrilação Atrial

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

5350

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

22 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.

Outros nomes:
  • Apple Watch
Comparador Ativo: 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.
Medicamento: Continuous DOAC therapy

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

Outros nomes:
  • Terapia de Anticoagulação Oral

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Johns Hopkins University

Colaboradores

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

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de julho de 2023

Conclusão Primária (Estimado)

31 de julho de 2029

Conclusão do estudo (Estimado)

31 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

19 de abril de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de abril de 2023

Primeira postagem (Real)

1 de maio de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB00354588
  • 1U24HL165066-01 (Concessão/Contrato do NIH dos EUA)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever