NCT05836987

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,350 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

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 history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

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 1-4 for men, 2-4 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	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.
DRUG	Continuous DOAC therapy	DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

Timeline

• Start date: 2023-07-13
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2023-05-01
• Last updated: 2026-04-09

Locations

93 sites across 1 country: United States

Regulatory

• FDA-regulated device study