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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation

NCT02608099

Atrial Fibrillation

COMPLETED PHASE4

A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation

NCT03382613

Atrial Fibrillation

TERMINATED

Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring

NCT01706146

Atrial Fibrillation

COMPLETED PHASE4

Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

NCT03508258

Non-valvular Atrial Fibrillation

WITHDRAWN

Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation

NCT06615596

Atrial Fibrillation (AF)

NOT_YET_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Tailored Anticoagulation (TAC)

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

Group Type EXPERIMENTAL

Drug (Direct thrombin or Factor Xa inhibitor)

Intervention Type OTHER

Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No