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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Other: Drug (Direct thrombin or Factor Xa inhibitor)

• Registration Number: NCT01650298
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-26
• Study Start: 2013-01
• Primary Completion: 2016-12
• Study Completion: 2017-08
• Results First Submitted: 2019-08-23
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Anticoagulation (TAC)	Drug (Direct thrombin or Factor Xa inhibitor)	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

Primary Outcome Measures

Name	Time	Method
Total Cumulative Days on Anticoagulation	one year	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.

Trial Locations

Locations (10)

Sparrow Research Institute; 🇺🇸 Lansing, Michigan, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Allegheny Singer Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio; 🇺🇸 San Antonio, Texas, United States

Jeffrey Goodman, MD; 🇺🇸 Los Angeles, California, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Samaritan Heart and Vascular Institute; 🇺🇸 Corvallis, Oregon, United States

Jefferson Heart Institute; 🇺🇸 Philadelphia, Pennsylvania, United States