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: December 11, 2013
Last verified: December 2013
  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:


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: January 2015
Estimated Primary Completion Date: January 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: December 11, 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 July 22, 2014