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Smartwatch-Guided DOAC Therapy for Atrial Fibrillation (REACT-AF Trial)

Phase 3
Recruiting
Led By Rod Passman
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of symptomatic or asymptomatic paroxysmal or persistent AF with duration > 30 seconds as documented by an external monitor or present on 12-lead ECG
The participant is on a DOAC at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 60 months
Awards & highlights

REACT-AF Trial Summary

This trial compares current AF treatment to a smart watch that senses AF and guides treatment for 1 month.

Who is the study for?
This trial is for adults aged 22-85 with a history of Atrial Fibrillation (AF) and low-to-moderate stroke risk, who can use a smartwatch and smartphone. They must be on DOAC therapy but willing to stop if needed, not at high risk for non-cardioembolic stroke, without severe heart conditions or other health issues that increase bleeding risks.Check my eligibility
What is being tested?
REACT-AF compares continuous Direct Oral Anticoagulation (DOAC) with time-limited DOAC guided by an AF-sensing Smart Watch (AFSW). Participants are randomly assigned to either continue their regular DOAC treatment or switch to using the smartwatch-guided method for one month.See study design
What are the potential side effects?
Potential side effects from DOACs include increased risk of bleeding, digestive system discomfort, headaches, dizziness, and allergic reactions. The severity of side effects varies among individuals.

REACT-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of irregular heartbeats lasting more than 30 seconds.
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I am currently taking a blood thinner that is not warfarin.
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I am between 22 and 85 years old.

REACT-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome 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.
Secondary outcome measures
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.

REACT-AF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AFSW Guided DOACExperimental Treatment1 Intervention
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.
Group II: Continuous DOAC therapyActive Control1 Intervention
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.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,832,147 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
2,299 Patients Enrolled for Atrial Fibrillation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,846,774 Total Patients Enrolled
45 Trials studying Atrial Fibrillation
534,243 Patients Enrolled for Atrial Fibrillation
Rod PassmanPrincipal InvestigatorNorthwestern University

Media Library

AFSW Guided DOAC Clinical Trial Eligibility Overview. Trial Name: NCT05836987 — Phase 3
Atrial Fibrillation Research Study Groups: AFSW Guided DOAC, Continuous DOAC therapy
Atrial Fibrillation Clinical Trial 2023: AFSW Guided DOAC Highlights & Side Effects. Trial Name: NCT05836987 — Phase 3
AFSW Guided DOAC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05836987 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include participants aged 75 and over?

"Adhering to the selection criteria for this trial, potential participants must be no younger than 22 and not older than 85 years of age."

Answered by AI

Who is eligible for participation in this clinical experiment?

"For admittance into this medical trial, the age requirement is between 22 and 85 years old with atrial fibrillation. The total recruitment quota for this study stands at 5350 patients."

Answered by AI

What risks are associated with AFSW Guided DOAC use?

"Our assessment of the safety profile for AFSW Guided DOAC earned a score of 3 due to its Phase 3 status, implying evidence-based efficacy and numerous positive results from trials dedicated to measuring safety."

Answered by AI

In what capacity are the various locations involved in this clinical trial?

"This trial involves 25 different clinical sites, including South Denver Cardiology Associates, P.C. in Littleton, St. Elizabeth's Medical Center in Washington and the Medical Faculty Associates George Washington University in Clearwater among other locations."

Answered by AI

Is this research seeking to onboard new participants?

"Based on the information hosted at clinicaltrials.gov, it appears that recruitment for this trial has ceased as of May 2nd 2023. However, there are still 492 other studies actively searching for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Columbia University Medical Center
University of Cincinnati College of Medicine
University Health Truman Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

thought i could help.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
2023. "The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05836987.
All > Afib > Atrial Fibrillation
~3567 spots leftby Jul 2029
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