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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by St. Jude Medical.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650298
First Posted: July 26, 2012
Last Update Posted: November 3, 2015
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.
Information provided by (Responsible Party):
St. Jude Medical
July 23, 2012
July 26, 2012
November 3, 2015
January 2013
February 2017   (Final data collection date for primary outcome measure)
All cause heart failure, cardiovascular, and stroke hospitalizations and death [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01650298 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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: None (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.
 
Unknown status
200
June 2017
February 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01650298
60039204/C
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Peter Zimetbaum, MD Beth Israel Deaconess Medical Center
St. Jude Medical
November 2015

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