Text Size

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
  Purpose

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 Intervention
Atrial Fibrillation
 Other: Drug (Direct thrombin or Factor Xa inhibitor)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study: Tailored Anticoagulation for Noncontinuous AF

Resource links provided by NLM:

Drug Information available for: Thrombin
U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All cause heart failure, cardiovascular, and stroke hospitalizations and death [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650298

Locations
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
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01650298     History of Changes
Other Study ID Numbers: 60039204/C
Study First Received: July 23, 2012
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013