5350 Participants Needed

Smartwatch-Guided DOAC Therapy for Atrial Fibrillation

(REACT-AF Trial)

Recruiting at 88 trial locations
NO
ER
SS
AV
DD
Overseen ByDawood Darbar
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Johns Hopkins University
Must be taking: DOACs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking blood-thinning medication continuously or only when a smart watch detects an irregular heartbeat is better for adults with a history of irregular heartbeats and moderate stroke risk.

Will I have to stop taking my current medications?

Participants must be willing to stop taking their current Direct Oral Anticoagulant (DOAC) medication for the study. If you are on other medications like aspirin or NSAIDs, you may need to stop them if they are not within current medical guidelines.

Is Apixaban (Eliquis) generally safe for humans?

Apixaban, a direct oral anticoagulant, is generally considered safe for humans and has a lower risk of causing serious bleeding in the brain compared to older treatments like warfarin. However, its safety in people with liver disease or those needing kidney treatment is not well understood.12345

What makes the AFSW Guided DOAC therapy unique for atrial fibrillation?

The AFSW Guided DOAC therapy is unique because it uses a smartwatch to guide the administration of direct-acting oral anticoagulants (DOACs) like Apixaban, which helps in preventing strokes in patients with atrial fibrillation. This approach may offer a more personalized and continuous monitoring method compared to traditional DOAC therapy, potentially improving adherence and outcomes.16789

What data supports the effectiveness of the drug Apixaban for atrial fibrillation?

Research shows that Apixaban, a direct-acting oral anticoagulant (DOAC), is effective in preventing stroke in patients with atrial fibrillation. It has been found to be as effective as warfarin, a traditional blood thinner, but with a lower risk of causing serious bleeding in the brain.1281011

Who Is on the Research Team?

RP

Rod Passman

Principal Investigator

Northwestern University

DH

Dan Hanley

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a history of irregular heartbeats lasting more than 30 seconds.
Willing and able to comply with the protocol, including possession of a smartwatch-compatible smartphone with a cellular service plan, willingness to wear the Apple watch at least 14 hours a day, expected to be within cellular service range at least 80% of the time, willingness and ability to discontinue DOAC, and willingness and ability to provide informed consent
I am currently taking a blood thinner that is not warfarin.
See 2 more

Exclusion Criteria

I am taking aspirin or similar drugs regularly and cannot stop for the study.
My kidney function is severely reduced.
I have atrial flutter that hasn't been treated with ablation.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either AFSW-guided, time-delimited DOAC therapy or continuous DOAC therapy

60 months
Regular monitoring through the REACT-AF app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AFSW Guided DOAC
  • Continuous DOAC therapy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: AFSW Guided DOACExperimental Treatment1 Intervention
Group II: Continuous DOAC therapyActive Control1 Intervention

AFSW Guided DOAC is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Eliquis for:
🇺🇸
Approved in United States as Eliquis for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

Direct-acting oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban are effective alternatives to traditional vitamin K antagonists for preventing strokes in patients with atrial fibrillation, showing comparable efficacy and a lower risk of intracranial bleeding.
DOACs are particularly beneficial for older adults due to their strategic dosing and lack of need for regular blood testing, but they are not recommended for patients with mechanical heart valves or severe mitral stenosis, and their safety in patients with liver disease and those on renal replacement therapy is still uncertain.
Direct-Acting Oral Anticoagulants in Atrial Fibrillation: What's New in the Literature.Ferrari, F., da Silveira, AD., Martins, VM., et al.[2023]
A study involving 91 patients and 184 samples found that apixaban and rivaroxaban levels in plasma can be effectively monitored using conventional tests like PT and dRVVT, indicating their reliability for assessing anticoagulant effects.
The established on-therapy ranges for both apixaban and rivaroxaban provide valuable benchmarks for clinicians to ensure effective and safe dosing in patients undergoing treatment with these direct oral anticoagulants.
Evaluation of global laboratory methods and establishing on-therapy ranges for monitoring apixaban and rivaroxaban: Experience at a single institution.Park, SH., Seo, YH., Park, PW., et al.[2021]
In a study of 4734 hospitalized patients with atrial fibrillation (AF), 60.5% were eligible for apixaban trials, 52.6% for dabigatran, and 35.8% for rivaroxaban, indicating that apixaban and dabigatran trials are more representative of this patient population.
About 33.4% of patients were eligible for all three DOAC trials, suggesting that the findings from these trials can be applied to a significant portion of hospitalized AF patients, particularly for apixaban and dabigatran.
The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation.Fanning, L., Ilomäki, J., Bell, JS., et al.[2018]

Citations

Direct-Acting Oral Anticoagulants in Atrial Fibrillation: What's New in the Literature. [2023]
Evaluation of global laboratory methods and establishing on-therapy ranges for monitoring apixaban and rivaroxaban: Experience at a single institution. [2021]
The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation. [2018]
Comparative Effectiveness of Interventions for Stroke Prevention in Atrial Fibrillation: A Network Meta-Analysis. [2023]
How lower doses of direct oral anticoagulants are interpreted in clinical practice: a national survey of the Italian Atherosclerosis, Thrombosis and Vascular Biology (ATVB) Study Group. [2023]
First experience with edoxaban and atrial fibrillation ablation - Insights from the ENGAGE AF-TIMI 48 trial. [2018]
Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study. [2022]
Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]
Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or Full Dose Direct-Acting Oral Anticoagulant. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness and Safety of DOACs in Atrial Fibrillation Patients Undergoing Catheter Ablation: Results from the China Atrial Fibrillation (China-AF) Registry. [2022]
Safety of radial coronary angiography with uninterrupted direct-acting oral anticoagulant treatment. [2019]
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