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Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT COM)

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ClinicalTrials.gov Identifier: NCT01706146
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : February 22, 2016
Last Update Posted : March 23, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Medtronic
Information provided by (Responsible Party):
Alexandru B Chicos, Northwestern University

Tracking Information
First Submitted Date  ICMJE October 10, 2012
First Posted Date  ICMJE October 15, 2012
Results First Submitted Date  ICMJE January 25, 2016
Results First Posted Date  ICMJE February 22, 2016
Last Update Posted Date March 23, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Number of Days on Anticoagulation [ Time Frame: up to 12 months ]
Assess subject anticoagulant utilization and number of days on anticoagulation
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
Anticoagulant Utilization [ Time Frame: 12 months ]
Assess subject anticoagulant utilization and proportion of time off anticoagulation
Change History Complete list of historical versions of study NCT01706146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
Bleeding Incidence [ Time Frame: up to 12 months ]
To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2012)
Bleeding rate [ Time Frame: 12 months ]
To assess the bleeding rate with implantable monitor-guided intermittent anticoagulation.
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2016)
  • Stroke Rate [ Time Frame: 12 months ]
    To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.
  • Overall Survival [ Time Frame: 12 months ]
    To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.
  • Major Bleeding-free Survival Rate [ Time Frame: 12 months ]
    To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.
  • Stroke-free Survival Rate [ Time Frame: 12 months ]
    To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.
Original Other Pre-specified Outcome Measures
 (submitted: October 12, 2012)
  • Stroke Rate [ Time Frame: 12 months ]
    To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.
  • Overall Survival [ Time Frame: 12 months ]
    To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.
  • Major Bleeding-free Survival Rate [ Time Frame: 12 months ]
    To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.
  • Stroke-free Survival Rate [ Time Frame: 12 months ]
    To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.
  • Quality of life assessment [ Time Frame: 12 months ]
    To assess the quality of life with implantable monitor-guided intermittent anticoagulation.
 
Descriptive Information
Brief Title  ICMJE Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Official Title  ICMJE Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE 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)
Study Arms  ICMJE 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.
Intervention: Drug: Non-coumadin Oral Anticoagulant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2014)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2012)
75
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01706146
Other Study ID Numbers  ICMJE STU00064217
1R34HL113404-01 ( U.S. NIH Grant/Contract )
7R34HL113404-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandru B Chicos, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Medtronic
Investigators  ICMJE
Principal Investigator: Alexandru Chicos, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP