Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation (TACTIC AF)

Abbott

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Other: Drug (Direct thrombin or Factor Xa inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01650298

60039204/C

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Control

No Intervention group

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

Tailored Anticoagulation (TAC)

Experimental group

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

Treatment:

Other: Drug (Direct thrombin or Factor Xa inhibitor)