Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT COM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northwestern University
Sponsor:
Collaborators:
Medtronic
Information provided by (Responsible Party):
Rod Passman, Northwestern University
ClinicalTrials.gov Identifier:
NCT01706146
First received: October 10, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Non-coumadin Oral Anticoagulant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Anticoagulant Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess subject anticoagulant utilization and proportion of time off anticoagulation


Secondary Outcome Measures:
  • Bleeding rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess the bleeding rate with implantable monitor-guided intermittent anticoagulation.


Other Outcome Measures:
  • Stroke rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.

  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.

  • Major bleeding-free survival rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.

  • Stroke-free survival rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.

  • Quality of life assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess the quality of life with implantable monitor-guided intermittent anticoagulation.


Estimated Enrollment: 75
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706146

Contacts
Contact: Anna L Huskin, RN 312-695-4067 ahuskin@nmh.org

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna L Huskin, RN    312-695-4067    ahuskin@nmh.org   
Principal Investigator: Rod S Passman, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer Kaufman    617-632-8956    jmkaufma@bidmc.harvard.edu   
Principal Investigator: Peter Zimetbaum, MD         
Canada, Ontario
University of Western Ontario Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Denise Hulley    519-685-8500 ext 34852    denise.hulley@lhsc.on.ca   
Principal Investigator: George J. Klein, MD         
Sponsors and Collaborators
Northwestern University
Medtronic
Investigators
Principal Investigator: Rod S Passman, MD Northwestern University
  More Information

No publications provided

Responsible Party: Rod Passman, Medical Director, Bluhm Cardiovascular Institute Program for Atrial Fibrillation; Associate Director, Cardiac Electrophysiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01706146     History of Changes
Other Study ID Numbers: STU00064217, 1R34HL113404-01
Study First Received: October 10, 2012
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Northwestern University:
atrial fibrillation
reveal xt
oral anticoagulation
dabigatran
rivaroxaban
apixaban

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014