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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01650298
First received: July 23, 2012
Last updated: February 6, 2013
Last verified: February 2013
History of Changes

July 23, 2012
February 6, 2013
January 2013
September 2014   (final data collection date for primary outcome measure)
All cause heart failure, cardiovascular, and stroke hospitalizations and death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01650298 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
Pilot Study: Tailored Anticoagulation for Noncontinuous AF

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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Atrial Fibrillation
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).
  • 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
    Intervention: Other: Drug (Direct thrombin or Factor Xa inhibitor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01650298
60039204/C
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Peter Zimetbaum, MD Beth Israel Deaconess Medical Center
St. Jude Medical
February 2013

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