Smartwatch-Guided DOAC Therapy for Atrial Fibrillation

(REACT-AF Trial)

Recruiting in Palo Alto (17 mi)

+88 other locations

Overseen by Rod Passman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Johns Hopkins University

Must be taking: DOACs

Must not be taking: Warfarin, Aspirin, NSAIDs

Disqualifiers: Valvular AF, Pregnancy, Hypertrophic cardiomyopathy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 3 9 10 11}

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• AFSW Guided DOAC (Device)
• Continuous DOAC therapy (Anticoagulant)

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.

Participant Groups

Group I: AFSW Guided DOAC Experimental Treatment 1 Intervention

All participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. 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.

Group II: Continuous DOAC therapy Active Control 1 Intervention

All participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.

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

🇪🇺 Approved in European Union as Eliquis for:

• Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
• Prevention of deep vein thrombosis and pulmonary embolism after hip or knee replacement surgery
• Treatment of deep vein thrombosis and pulmonary embolism

🇺🇸 Approved in United States as Eliquis for:

• Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
• Prevention of deep vein thrombosis and pulmonary embolism after hip or knee replacement surgery
• Treatment of deep vein thrombosis and pulmonary embolism

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Evanston, IL

Emory University Atlanta, GA

Mayo Clinic Jacksonville, FL

Beth Israel Deaconess Medical Center Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Direct-Acting Oral Anticoagulants in Atrial Fibrillation: What's New in the Literature. [2023] Atrial fibrillation (AF) is considered the most common sustained cardiac arrhythmia, and it is associated with a significant risk of adverse events, especially ischemic stroke. Oral anticoagulation is the cornerstone for stroke prevention in AF; for many years, only vitamin K antagonists were used for this purpose, with an absolute risk reduction >60%. However, these agents have limitations, such as narrow therapeutic margins and drug-food and drug-drug interactions. More recently, 4 direct-acting oral anticoagulants (DOACs)-non-vitamin K antagonists-have become available for patients with AF: dabigatran, rivaroxaban, apixaban, and edoxaban. In addition to a comparable efficacy to warfarin in large randomized controlled trials, DOACs were found to promote a lower risk of intracranial bleeding. The strategic dosage and lack of need for periodic prothrombin-time testing make their use attractive, especially for primary or secondary prevention of stroke in older adults. Furthermore, among patients with AF presenting with acute coronary syndrome or undergoing percutaneous coronary intervention, apixaban is associated with a reduction in serious bleeding events when compared with warfarin. On the other hand, there is no evidence of benefit of DOACs in patients with mechanical prosthetic valves or moderate/severe mitral stenosis. Furthermore, the suitability of DOACs in patients with liver disease is still poorly understood, and their safety in patients requiring renal replacement therapy remains uncertain. This review provides an overview of the main trials of DOACs, their pharmacology and safety profile, clinical implications, and best indications in light of the current evidence.

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of global laboratory methods and establishing on-therapy ranges for monitoring apixaban and rivaroxaban: Experience at a single institution. [2021] Apixaban and rivaroxaban are approved for the prevention and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and embolic stroke in atrial fibrillation (AF) patients. The aim of this study was to find appropriate methods of monitoring the anticoagulant effects of are direct oral anticoagulants (DOACs) and establish on-therapy ranges using conventional tests.

3. Germany pubmed.ncbi.nlm.nih.gov

The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation. [2018] Trials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF.

4. England pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Interventions for Stroke Prevention in Atrial Fibrillation: A Network Meta-Analysis. [2023] The goal of this study was to compare the safety and effectiveness of individual antiembolic interventions in nonvalvular atrial fibrillation (AF): novel oral anticoagulants (NOACs) (apixaban, dabigatran, edoxaban, and rivaroxaban); vitamin K antagonists (VKA); aspirin; and the Watchman device.

5. United States pubmed.ncbi.nlm.nih.gov

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] To evaluate the current interpretation of the lower doses of direct oral anticoagulants (DOAC) dabigatran, apixaban, edoxaban and rivaroxaban in nonvalvular atrial fibrillation.

6. Netherlands pubmed.ncbi.nlm.nih.gov

First experience with edoxaban and atrial fibrillation ablation - Insights from the ENGAGE AF-TIMI 48 trial. [2018] Atrial fibrillation (AF) ablation procedures are increasingly being performed in patients receiving direct oral anticoagulants (DOACs). Experience regarding the safety of edoxaban in this context is limited. In an exploratory analysis we therefore investigated the outcome of patients undergoing transcatheter AF ablation in the ENGAGE AF-TIMI 48 trial.

7. Netherlands pubmed.ncbi.nlm.nih.gov

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] The aim of the study was to compare the real-world effectiveness and safety in atrial fibrillation (AF) patients treated with edoxaban versus other oral anticoagulants (OACs) (apixaban, dabigatran, rivaroxaban, and vitamin K antagonists [VKA]) in Germany.

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021] Label="BACKGROUND">Apixaban (ELIQUIS®) is a direct oral anticoagulant authorised for multiple indications in the European Economic Area (EEA). Additional risk minimisation measures (aRMMs) to address the risk of bleeding include educational materials comprising a Prescriber Guide and Patient Alert Card.

9. Ireland pubmed.ncbi.nlm.nih.gov

Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or Full Dose Direct-Acting Oral Anticoagulant. [2022] Direct-acting oral anticoagulants (DOACs) represent the standard for preventing stroke and systemic embolization (SSE) in patients with atrial fibrillation (AF). There is limited information for patients ≥ 80 years. We report a retrospective analysis of AF patients ≥ 80 years prescribed either a US Food and Drug Administration (FDA)-approved reduced (n = 514) or full dose (n = 199) DOAC (Dabigatran, Rivaroxaban, or Apixaban) between January 1st, 2011 (first DOAC commercially available) and May 31st, 2017. The following multivariable differences in baseline characteristics were identified: patients prescribed a reduced dose DOAC were older (p

10. United States pubmed.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] Direct oral anticoagulants (DOACs) have increasingly become an alternative to warfarin in atrial fibrillation (AF) patients. Nonetheless, data on the effectiveness and safety of DOACs in periprocedural of catheter ablation (CA) in real-world practice was relatively rare.

11. Turkey pubmed.ncbi.nlm.nih.gov

Safety of radial coronary angiography with uninterrupted direct-acting oral anticoagulant treatment. [2019] It is not known whether direct-acting oral anticoagulants (DOACs), such as dabigatran, apixaban, and rivaroxaban increase the risk of bleeding complications during or after coronary catheterization. The aim of this study was to investigate the safety of uninterrupted DOAC treatment during diagnostic radial coronary angiography (CAG).