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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22-85
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

22-85 years of age.

English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.

History of non-permanent atrial fibrillation.

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%.

Disqualifiers

Valvular or permanent atrial fibrillation.

Current treatment with warfarin and unwilling or unable to take a DOAC.

The participant is a woman who is pregnant or nursing.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AFSW Guided DOAC

    Device

    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.

  • Continuous DOAC therapy

    Drug

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

Treatment groups

5,350 Participants
are divided into 2 treatment groups
Group A: AFSW Guided DOACExperimental treatment 1 intervention
Group B: Continuous DOAC therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
At 60 months

Secondary outcomes

1

To assess whether AFSW-guided, time-delimited DOAC therapy significantly reduces major bleeding events compared to continuous DOAC therapy.

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.

Time frame
At 60 months

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Northwestern University

Collaborator

Source ClinicalTrials.gov
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