Back to resultsSafety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation (TACTIC AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drug (Direct thrombin or Factor Xa inhibitor)
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Jeffrey Goodman, MD
- Northwestern Memorial Hospital
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Sparrow Research Institute
- Hackensack University Medical Center
- Samaritan Heart and Vascular Institute
- Jefferson Heart Institute
- Allegheny Singer Research Institute
- STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Tailored Anticoagulation (TAC)
Arm Description
Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor
Anticoagulation 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01650298
Brief Title
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
Acronym
TACTIC AF
Official Title
Pilot Study: Tailored Anticoagulation for Noncontinuous AF
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to slow enrollment.
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor
Arm Title
Tailored Anticoagulation (TAC)
Arm Type
Experimental
Arm Description
Anticoagulation 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
Intervention Type
Other
Intervention Name(s)
Drug (Direct thrombin or Factor Xa inhibitor)
Intervention Description
Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
Primary Outcome Measure Information:
Title
Total Cumulative Days on Anticoagulation
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Zimetbaum, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeffrey Goodman, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Sparrow Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
76011
Country
United States
Facility Name
Samaritan Heart and Vascular Institute
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Jefferson Heart Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
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