UG3HL165065

The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation Trial (REACT-AF) - Project Summary / Abstract

Purpose:
The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation (REACT-AF) clinical trial will compare the efficacy and safety of two treatment strategies for stroke prevention in atrial fibrillation (AF). The trial will compare the current standard of continuous direct oral anticoagulation (DOAC) with a novel strategy of precision, time-delimited DOAC initiated only in response to a 1-hour AF episode detected by an AF-sensing smartwatch (AFSW - Apple Watch).

Rationale:
Stroke risk is often temporally related to AF onset and duration, but bleeding risk continues as a constant risk of anticoagulation exposure even during long AF-free periods when stroke risk may be low. REACT-AF will evaluate the benefits and risks of withholding anticoagulation during prolonged periods of sinus rhythm as guided by an AFSW. Compared with continuous DOAC, AFSW-guided, time-delimited DOAC treatment may reduce bleeding events while maintaining stroke protection. This has the potential to improve important major clinical outcomes and quality of life while reducing healthcare utilization.

Design:
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (probe design) trial comparing the current standard of care of continuous DOAC administration versus time-delimited DOAC treatment guided by an AFSW in patients with a history of paroxysmal or persistent AF and low-to-moderate stroke risk (CHA2DS2-VASC score 1-4). The study will have an initial explanatory Phase I followed by an explanatory Phase II with pragmatic elements.

Primary Aim 1 (Efficacy Objective):
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

Hypothesis:
Time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for the composite endpoint of ischemic stroke, systemic embolism, and all-cause mortality.

Primary Aim 2 (Safety Objective):
To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.

Hypothesis:
Major bleeding events will be significantly lower in participants randomized to AFSW-guided, time-delimited DOAC therapy compared with participants receiving continuous DOAC therapy.

Exploratory Aim 1:
To compare overall participant satisfaction with anticoagulation management between the two study arms.

Exploratory Aim 2:
To compare estimates of health-related resource utilization in participants randomized to control versus experimental arms.

Northwestern University

NOT APPLICABLE

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Chicago, Illinois 60611 United States

Single Zip Code

Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) (PAR-19-329)

Amendment Since initial award the total obligations have decreased 44% from $3,610,112 to $2,026,020.