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REACT-AF Study: Atrial Fibrillation and Anticoagulation

This study, called REACT-AF, is looking at a new way to manage atrial fibrillation (AF), a condition where your heart beats irregularly. It compares two approaches for using Direct Oral Anticoagulants (DOACs), which are medicines that prevent blood clots and reduce stroke risk. One group will take DOACs continuously, which is the standard treatment. The other group will use a special smart watch (AFSW) that detects AF. If the watch detects AF for a certain amount of time, you would take DOACs for 30 days. The study wants to see if this smart watch-guided approach is as effective as continuous DOAC therapy in preventing strokes, blood clots, and death over 60 months. You may be able to join if you are 22-85 years old, speak English, have a history of AF, and have a low to moderate risk of stroke.

Study design
This is a randomized, open-label study comparing two treatments, with 5350 participants planned. It is designed so that the people evaluating the results won't know which treatment participants received.
What's involved
Participants will be in the study for up to 60 months. If in the experimental group, you would take DOACs for 30 days after your smart watch detects an AF episode lasting over one hour.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05836987

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Recruiting
PHASE3Ages 22–85InterventionalPrevention
Johns Hopkins University
~5,350 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AFSW Guided DOACContinuous DOAC therapy

At a glance

Recruiting sites
85 of 93 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over At 60 months

Conditions

Atrial Fibrillation

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NCT05836987

Where you'd take part

This study runs at 93 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jerseystudy coordinator listed

    Recruiting

  • Alexian Brothers Health System

    Elk Grove Village, Illinoisstudy coordinator listed

    Recruiting

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Ascension St. Vincent

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • Banner University

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • BayCare Health Systems

    Clearwater, Floridastudy coordinator listed

    Recruiting

  • Baycare Health Systems Clearwater

    Winter Haven, Floridastudy coordinator listed

    Recruiting

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rod Passman · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Dan Hanley · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Shea Smith
[email protected]
650-724-6211
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • 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.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.