CLINICAL TRIAL / NCT05836987
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
- Interventional
- Active
- NCT05836987
REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
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.
REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center,
investigational clinical trial of men and women aged 22-85 with a documented history of
symptomatic or asymptomatic paroxysmal or persistent (AF) and a moderate risk of stroke
measured by CHA2DS2-VASc score 1-4 for men, 2-4 for women (which stands for Congestive
heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular
disease, age 65 to 74 and sex category (female)). Participants randomized to the
experimental arm (on demand DOAC) will take the participants DOAC for 30 consecutive days
following a qualifying AF episode (i.e., greater than1 hour) detected by the AFSW.
Participants randomized to the standard of care (control) arm will remain on previously
prescribed continuous DOAC throughout the study.
A total of 5350 participants will be enrolled across up to 100 study sites targeting
two-thirds academic and one-third private practices, with academic practices also
enrolling from affiliated community sites. The investigators anticipate evaluating 7643
consented individuals with external monitoring to ensure that a low AF burden population
will be randomized. Up to 200 participants may be enrolled at any one site, and
participation will last up to 60 months.
Gender
All
Age Group
22 Years to 85 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. 22-85 years of age.
2. English speaking participants. Spanish-only speakers may be included in the future
at select sites appropriately translated.
3. History of non-permanent atrial fibrillation.
4. 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%.
5. The participant is on a DOAC at the time of screening and willing to stay on DOAC
for duration of study.
6. Willing and able to comply with the protocol, including:
- Possession of a smart watch-compatible smart phone (iPhone that supports the
latest shipping iOS) with a cellular service plan
- Be willing to wear the smart watch for the suggested minimum of 14 hours a day
- Expected to be within cellular service range at least 80% of the time
7. Willing and able to discontinue DOAC
8. The participant is willing and able to provide informed consent.
Exclusion Criteria:
1. Valvular or permanent atrial fibrillation.
2. Current treatment with warfarin and unwilling or unable to take a DOAC.
3. The participant is a woman who is pregnant or nursing.
4. 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.
5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable
Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device
or planned insertable cardiac monitor. Insertable cardiac monitors are permitted
unless they are being used to guide anticoagulation treatment.
6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1
hour/month over the last 3 months.
7. Any documented single AF episode lasting ≥ 1 hour on standard of care or
study-provided external cardiac monitor of > 6 days duration performed within 45
days prior to randomization. Shorter monitoring durations may be acceptable for
inclusion at the discretion of the site PI based on the totality of monitoring data
and approval of the study PI.
8. Ablation for AF within the last 2 months.
9. Prior or anticipated left atrial appendage occlusion or ligation.
10. Mechanical prosthetic valve(s) or severe valve disease.
11. Hypertrophic cardiomyopathy.
12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism
resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs
permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant
carotid artery disease defined as stenosis > 75%) based on the investigator's
discretion.
14. The participant is enrolled, has participated within the last 30 days, or is
planning to participate in a concurrent drug and/or device study during the course
of this clinical trial. Co-enrollment in concurrent trials is only allowed with
documented pre-approval from the study manager; there is no concern that
co-enrollment could confound the results of this trial.
15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area
on the ipsilateral side that the AFSW may be worn.
16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.
17. Any concomitant condition that, in the investigator's opinion, would not allow safe
participation in the study (e.g., drug addiction, alcohol abuse).
18. Known hypersensitivity or contraindication to direct oral anticoagulants.
19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated
hyperthyroidism). AF ablation does not constitute reversible AF.
21. > 5% burden of premature atrial or ventricular depolarizations on pre-enrollment
cardiac monitoring.
22. History of atrial flutter that has not been treated with ablation (participants in
atrial flutter and have been ablated are eligible for enrollment).
23. Stage 4 or 5 chronic kidney disease.
24. Conditions associated with an increased risk of bleeding:
- Major surgery in the previous month
- Planned surgery or intervention in the next three months that would require
cessation of anticoagulation > 2 weeks.
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic
intra- articular bleeding
- Gastrointestinal hemorrhage within the past year unless the cause has been
permanently eliminated (e.g., by surgery)
- Symptomatic or endoscopically documented gastroduodenal ulcer disease in the
previous 30 days
- Hemorrhagic disorder or bleeding diathesis
- Need for anticoagulant treatment for disorders other than AF
- Uncontrolled hypertension (Systolic Blood Pressure >180 mmHg and/or Diastolic
Blood Pressure >100 mmHg)