Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— TACTIC AF  

Official title:

Pilot Study: Tailored Anticoagulation for Noncontinuous AF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01650298
• Other study ID #: 60039204/C
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2017

Study information

• Verified date: August 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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).

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Samaritan Heart and Vascular Institute	Corvallis	Oregon
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Sparrow Research Institute	Lansing	Michigan
United States	Jeffrey Goodman, MD	Los Angeles	California
United States	Jefferson Heart Institute	Philadelphia	Pennsylvania
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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