What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include Direct Oral Anticoagulants (DOACs) and antiarrhythmic drugs. DOACs, such as dabigatran, rivaroxaban, apixaban, and edoxaban, primarily increase the risk of bleeding, including gastrointestinal and intracranial hemorrhage. Antiarrhythmic drugs like amiodarone, sotalol, and dronedarone have their own side effects: amiodarone can cause thyroid dysfunction, pulmonary toxicity, liver enzyme abnormalities, and skin discoloration; sotalol may lead to bradycardia and QT interval prolongation, increasing the risk of torsades de pointes; and dronedarone has been linked to liver injury and should be avoided in patients with severe heart failure due to increased cardiovascular events.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation (AF), including Direct Oral Anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban, which are used to reduce the risk of stroke in AF patients. Additionally, the WATCHMAN Left Atrial Appendage Closure Device has been approved as an alternative to long-term warfarin therapy for stroke prevention in non-valvular AF patients. The WATCHMAN device, evaluated in the PREVAIL and PROTECT AF trials, is similar to the AF-sensing Smart Watch (AFSW) guided DOAC use in that it aims to manage anticoagulation based on AF episode monitoring. These advancements reflect a trend towards personalized and technology-driven approaches in AF management.

What other types of research exist?

Promising alternatives to AF-sensing Smart Watch (AFSW) guided DOAC use for AF patients in 2024 include: 1) Photoplethysmography-based smart wearable devices for continuous AF monitoring, which have shown feasibility in real-world settings. 2) AI-enhanced rhythm monitoring systems that improve AF detection rates and guide personalized treatment plans. 3) Non-vitamin K antagonist oral anticoagulants (NOACs) tailored for specific patient profiles, especially in special populations like cancer patients. 4) Advanced rhythm control therapies, including catheter ablation and novel antiarrhythmic drugs, which may offer better outcomes for certain patients.

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Smartwatch-Guided DOAC Therapy for Atrial Fibrillation (REACT-AF Trial)

Phase 3

Recruiting

Led By Rod Passman

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented history of symptomatic or asymptomatic paroxysmal or persistent AF with duration > 30 seconds as documented by an external monitor or present on 12-lead ECG

The participant is on a DOAC at the time of screening

Must not have

The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines and is unwilling or unable to discontinue use for the study duration

Stage 4 or 5 chronic kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 60 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from DOACs include increased risk of bleeding, digestive system discomfort, headaches, dizziness, and allergic reactions. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of irregular heartbeats lasting more than 30 seconds.

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I am currently taking a blood thinner that is not warfarin.

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I am between 22 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking aspirin or similar drugs regularly and cannot stop for the study.

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My kidney function is severely reduced.

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I have atrial flutter that hasn't been treated with ablation.

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My atrial fibrillation can be treated or reversed.

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I am a woman who could become pregnant and am not using birth control.

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I have heart failure with an ejection fraction less than 40%.

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I have a heart valve issue or permanent atrial fibrillation.

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I have a mechanical heart valve or severe valve disease.

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I need blood thinners for reasons other than preventing stroke from AF.

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I have had a stroke or a mini-stroke before.

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I have a condition that increases my risk of bleeding.

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My high blood pressure is not under control.

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I am taking warfarin and cannot or do not want to switch to a DOAC.

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I have been diagnosed with thickened heart muscles.

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I am allergic or cannot take blood thinning pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AFSW Guided DOACExperimental Treatment1 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 therapyActive Control1 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Direct Oral Anticoagulants (DOACs) are commonly used in the treatment of Atrial Fibrillation (AF) to prevent stroke and systemic embolism. DOACs, such as dabigatran, rivaroxaban, apixaban, and edoxaban, work by inhibiting specific clotting factors (thrombin or factor Xa), thereby reducing the blood's ability to form clots. This is particularly important for AF patients, as irregular heartbeats can lead to the formation of blood clots in the atria, which can travel to the brain and cause a stroke. Monitoring AF episodes with devices like the AF-sensing Smart Watch (AFSW) allows for timely adjustments in anticoagulation therapy, ensuring that patients receive the right amount of medication when they are most at risk, thereby optimizing treatment efficacy and minimizing bleeding risks.

Atrial fibrillation.Choosing a particular oral anticoagulant and dose for stroke prevention in individual patients with non-valvular atrial fibrillation: part 2.