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Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation (TACTIC AF)

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.
 
ClinicalTrials.gov Identifier: NCT01650298
Recruitment Status : Terminated (Due to slow enrollment.)
First Posted : July 26, 2012
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Drug (Direct thrombin or Factor Xa inhibitor) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Arm Intervention/treatment
No Intervention: Control
Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor
Experimental: Tailored Anticoagulation (TAC)

Anticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net.

Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed

Other: Drug (Direct thrombin or Factor Xa inhibitor)
Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).




Primary Outcome Measures :
  1. Total Cumulative Days on Anticoagulation [ Time Frame: one year ]
    To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.



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
Criteria

Inclusion Criteria:

  • Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)
  • Patient has history of atrial fibrillation (non-continuous)
  • Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation
  • Patient is willing to complete a questionnaire

Exclusion Criteria:

  • Patient is in atrial fibrillation all of the time
  • Patient has a history of stroke or blood clot
  • Patient is on warfarin or coumadin
  • Patient cannot be taken off of his blood thinner medication due to another medical condition
  • Patient is not capable of sending a remote device transmission to doctor once a week

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 ClinicalTrials.gov identifier (NCT number): NCT01650298


Locations
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United States, California
Jeffrey Goodman, MD
Los Angeles, California, United States, 90048
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Sparrow Research Institute
Lansing, Michigan, United States, 48912
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 76011
United States, Oregon
Samaritan Heart and Vascular Institute
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States, 19107
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Peter Zimetbaum, MD Beth Israel Deaconess Medical Center
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01650298    
Other Study ID Numbers: 60039204/C
First Posted: July 26, 2012    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Factor Xa Inhibitors
Thrombin
Hemostatics
Coagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants