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Atrial FibrillationPhase 4REACT COMNCT01706146

Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring

A Phase 4 study testing Non-coumadin Oral Anticoagulant in people with Atrial Fibrillation, run by Northwestern University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Non-coumadin Oral Anticoagulant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
3 sitesin 2 countries
Study dates
Oct 2012to Feb 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria:
  • Age 18 and above.
  • Patients with non-valvular, non-continuous AF and either:
  • Infrequent AF episodes without a rhythm control strategy who have had no documented AF lasting > 1 hour for 3 consecutive months (the last 2 of which are on a previously implanted Reveal XT implantable cardiac monitor), or (B) Previous or current rhythm control strategy. Rhythm control strategies may include: i. Class I or Class III antiarrhythmic drugs ii. Pulmonary vein isolation iii. Post-MAZE/minimally invasive MAZE
  • Current Reveal XT implant prior to study enrollment.
  • Documented clinical history of symptomatic or asymptomatic paroxysmal, long-standing persistent or persistent AF prior to rhythm control initiation. The duration of AF must have been > 30 seconds as documented by an external monitor, present 12 lead ECG, or Reveal XT.
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  • CHADS2 score of 1 or 2
  • Candidates for chronic anticoagulation with an FDA-approved non-Coumadin oral anticoagulant (dabigatran, rivaroxaban, apixaban), based on the discretion of the treating physician.
  • Demonstrated ability to tolerate dabigatran 150mg/BID (if CrCl >30ml/min), rivaroxaban 15mg QD (if CrCl 15-49 ml/min) and 20mg QD (if CrCl ≥50ml/min), or apixaban 5mg BID or 2.5 mg for subjects with ≥2 of the following: age ≥ 80 years, body weight ≤60kg, serum creatinine ≥1.5 mg/dl.
  • Able and willing to provide written informed consent and willing to follow instructions, attend all required study visits, and undergo all planned tests.
  • Subject must be willing and able to discontinue oral anticoagulation for the purposes of this study

Who cannot join

  • Patients should not have any of the following criteria:
  • Permanent AF
  • Any documented single AF episode lasting ≥ 1 hour per month over two consecutive months prior to study enrollment.
  • Mechanical prosthetic valves or severe valve disease.
  • CHADS2 score of 0, or > 2
  • Subject deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease) based on discretion of the investigator.
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  • Individual is pregnant, nursing, or planning to become pregnant.
  • Known hypersensitivity to non-Coumadin oral anticoagulants.
  • Documented prior stroke or transient ischemic attack.
  • Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
  • Conditions associated with an increased risk of bleeding:
  • Major surgery in the previous month
  • Planned surgery or intervention in the next 3 months.
  • 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
  • Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment
  • Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg)
  • Recent malignancy or radiation therapy (≤6 months)
  • Anemia (hemoglobin <10g/dL) or thrombocytopenia (platelet count <100K/UL)
  • Patients who have received an investigational drug in the past 30 days or are participating in a drug study.
  • Intolerance or hypersensitivity to low dose aspirin therapy
  • Life expectancy less than the expected duration of the trial due to concomitant disease.
  • Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
  • Inability to comply with daily data transmission requirements.
  • Known history of isolated atrial flutter/atrial tachycardia without atrial fibrillation.
  • More than 10 false positive atrial fibrillation events lasting > 30 minutes per month for two months prior to enrollment on a previously implantable cardiac monitor.
  • Severe renal impairment (CrCl < 15 ml/min)

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

Canada1 site

  • University of Western Ontario

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death. For those with AF and other stroke risk factors, chronic anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if the AF is infrequent or short-lived. This standard of care is based partly on our inability to rapidly recognize and respond to AF recurrences which can often be brief and asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged periods of sinus rhythm where the risk of stroke is presumably low.

Recent advances in device technology and drug therapy, however, have the potential to change the way the investigators manage AF. The use of a small leadless subcutaneous implantable cardiac monitor with remote data transmission capabilities (Reveal XT, Medtronic Inc.) provides the ability to remotely and continuously evaluate a patient for AF recurrences, even episodes that are brief and asymptomatic. In addition, release of unique oral thrombin inhibitor approved for use in non-valvular AF(Dabigatran [Pradaxa], Rivaroxaban [Xarelto]) allows for rapid onset anticoagulation within minutes to hours of a single oral dose. Together, these advances allow for continuous AF monitoring with targeted anticoagulation only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage while still protecting against stroke.

The aim of this pilot study is to assess the feasibility of intermittent anticoagulation with a rapid-onset oral thrombin inhibitor guided by a continuous AF-sensing implantable cardiac monitor (Reveal XT) with remote data transmission capabilities.

Being tested
Non-coumadin Oral Anticoagulant
Keywords
atrial fibrillation, reveal xt, oral anticoagulation, dabigatran, rivaroxaban, apixaban
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-coumadin Oral AnticoagulantDrug

    Also called Including but not limited to:, Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis)

    Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.

Study groups in NCT01706146
Study groupRoleWhat they receive
Non-Coumadin Oral AnticoagulantOtherAdministration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Receives: Drug: Non-coumadin Oral Anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Days on Anticoagulation

    Assess subject anticoagulant utilization and number of days on anticoagulation

    Measured: up to 12 months

Secondary outcomes (1)

  1. Bleeding Incidence

    To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706146
Sponsor's protocol ID
STU00064217
Other IDs
1R34HL113404-01, 7R34HL113404-03
Acronym
REACT COM
Status last verified
Feb 2016
First submitted
10 Oct 2012
Last updated
23 Mar 2016
Data monitoring committee
Yes

Publications

  • Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.

    PubMed 26511221

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Non-coumadin Oral Anticoagulant in people with Atrial Fibrillation, run by Northwestern University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days on Anticoagulation (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706146, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.

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