Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial.
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Lopes RD
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: renato.lopes@duke.edu.
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Alings M
Working Group on Cardiovascular Research, Utrecht, the Netherlands.
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Connolly SJ
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
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Beresh H
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
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Granger CB
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
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Mazuecos JB
Hospital Universitario Fundación Jimenez Díaz-Quironsalud, Madrid, Spain.
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Boriani G
Cardiology Division, Department of Diagnostics, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena University Hospital, Modena, Italy.
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Nielsen JC
Aarhus University Hospital, Aarhus, Denmark.
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Conen D
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada; Department of Medicine, University Hospital, Basel, Switzerland.
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Hohnloser SH
Department of Cardiology, Johann Wolfgang Goethe University Hospital, Frankfurt, Germany.
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Mairesse GH
Cliniques du Sud Luxembourg, Arlon, Belgium.
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Mabo P
Hôpital Pontchaillou, Rennes, France.
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Camm AJ
St George's University of London and Imperial College London, London, United Kingdom.
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Healey JS
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
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Published in:
- American heart journal. - 2017
English
BACKGROUND
Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown.
DESIGN
ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic embolism. Approximately 4,000 patients will be enrolled from around 230 clinical sites, with an anticipated mean follow-up of 36months until 248 adjudicated primary outcome events have occurred.
SUMMARY
ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with subclinical AF and additional risk factors.
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Language
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Open access status
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green
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Persistent URL
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https://sonar.ch/global/documents/17860
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