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

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ClinicalTrials.gov Identifier: NCT01650298
Recruitment Status : Unknown
Verified November 2015 by St. Jude Medical.
Recruitment status was:  Enrolling by invitation
First Posted : July 26, 2012
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF
Study Start Date : January 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Arm Intervention/treatment
No Intervention: Anticoagulation taken as prescribed by doctor
Anticoagulation to be stopped/started per device information
Other: The physician will manage the patient's anticoagulation medication by weekly remote monitoring device transmissions
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. All cause heart failure, cardiovascular, and stroke hospitalizations and death [ Time Frame: one year ]


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
United States, California
Jeffrey Goodman, MD
Los Angeles, California, United States
United States, Michigan
Sparrow Research Institute
Lansing, Michigan, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 76011
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Peter Zimetbaum, MD Beth Israel Deaconess Medical Center

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01650298     History of Changes
Other Study ID Numbers: 60039204/C
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

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