Study Stopped
Due to slow enrollment.
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
TACTIC AF
Pilot Study: Tailored Anticoagulation for Noncontinuous AF
1 other identifier
interventional
64
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Jan 2013
Longer than P75 for not_applicable atrial-fibrillation
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
August 13, 2020
CompletedAugust 13, 2020
August 1, 2020
3.9 years
July 23, 2012
August 23, 2019
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Total Cumulative Days on Anticoagulation
To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.
one year
Study Arms (2)
Control
NO INTERVENTIONRemote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor
Tailored Anticoagulation (TAC)
EXPERIMENTALAnticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Jeffrey Goodman, MD
Los Angeles, California, 90048, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Sparrow Research Institute
Lansing, Michigan, 48912, United States
Hackensack University Medical Center
Hackensack, New Jersey, 76011, United States
Samaritan Heart and Vascular Institute
Corvallis, Oregon, 97330, United States
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grant Kim
- Organization
- ABBOTT
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Zimetbaum, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2012
First Posted
July 26, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2016
Study Completion
August 1, 2017
Last Updated
August 13, 2020
Results First Posted
August 13, 2020
Record last verified: 2020-08