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Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT COM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706146
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : February 22, 2016
Last Update Posted : March 23, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alexandru B Chicos, Northwestern University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Non-coumadin Oral Anticoagulant Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Study Start Date : October 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Non-Coumadin Oral Anticoagulant
Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Drug: Non-coumadin Oral Anticoagulant
Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
Other Names:
  • Including but not limited to:
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Apixaban (Eliquis)

Primary Outcome Measures :
  1. Number of Days on Anticoagulation [ Time Frame: up to 12 months ]
    Assess subject anticoagulant utilization and number of days on anticoagulation

Secondary Outcome Measures :
  1. Bleeding Incidence [ Time Frame: up to 12 months ]
    To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.

Other Outcome Measures:
  1. Stroke Rate [ Time Frame: 12 months ]
    To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.

  2. Overall Survival [ Time Frame: 12 months ]
    To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.

  3. Major Bleeding-free Survival Rate [ Time Frame: 12 months ]
    To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.

  4. Stroke-free Survival Rate [ Time Frame: 12 months ]
    To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must meet all of the following criteria:

  1. Age 18 and above.
  2. Patients with non-valvular, non-continuous AF and either:

    (A) 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

  3. Current Reveal XT implant prior to study enrollment.
  4. 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.
  5. CHADS2 score of 1 or 2
  6. Candidates for chronic anticoagulation with an FDA-approved non-Coumadin oral anticoagulant (dabigatran, rivaroxaban, apixaban), based on the discretion of the treating physician.
  7. 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.
  8. Able and willing to provide written informed consent and willing to follow instructions, attend all required study visits, and undergo all planned tests.
  9. Subject must be willing and able to discontinue oral anticoagulation for the purposes of this study

Exclusion Criteria:

Patients should not have any of the following criteria:

  1. Permanent AF
  2. 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.

  3. CHADS2 score of 0, or > 2
  4. Subject deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease) based on discretion of the investigator.
  5. Individual is pregnant, nursing, or planning to become pregnant.
  6. Known hypersensitivity to non-Coumadin oral anticoagulants.
  7. Documented prior stroke or transient ischemic attack.
  8. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
  9. 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)
  10. Recent malignancy or radiation therapy (≤6 months)
  11. Anemia (hemoglobin <10g/dL) or thrombocytopenia (platelet count <100K/UL)
  12. Patients who have received an investigational drug in the past 30 days or are participating in a drug study.
  13. Intolerance or hypersensitivity to low dose aspirin therapy
  14. Life expectancy less than the expected duration of the trial due to concomitant disease.
  15. Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
  16. Inability to comply with daily data transmission requirements.
  17. Known history of isolated atrial flutter/atrial tachycardia without atrial fibrillation.
  18. 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.
  19. Severe renal impairment (CrCl < 15 ml/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01706146

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Alexandru Chicos, MD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexandru B Chicos, Director, Cardiac Electrophysiology Laboratory Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Northwestern University Identifier: NCT01706146     History of Changes
Other Study ID Numbers: STU00064217
1R34HL113404-01 ( U.S. NIH Grant/Contract )
7R34HL113404-03 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2012    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: March 23, 2016
Last Verified: February 2016

Keywords provided by Alexandru B Chicos, Northwestern University:
atrial fibrillation
reveal xt
oral anticoagulation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action