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
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 1-4 for men and 2-4 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 aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
Trial design
Treatments tested in this trial
- AFSW Guided DOAC
- Continuous DOAC therapy
Treatment groups
5,350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Northwestern University
Collaborator
Source ClinicalTrials.gov