The AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke randomized trial: Rationale and methods

DOI Web Site Web Site 被引用文献9件
  • Hooman Kamel
    Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medical College, New York, NY, USA
  • WT Longstreth
    Department of Neurology, University of Washington, Seattle, WA, USA
  • David L Tirschwell
    Department of Neurology, University of Washington, Seattle, WA, USA
  • Richard A Kronmal
    Department of Biostatistics, University of Washington, Seattle, WA
  • Joseph P Broderick
    Department of Neurology, University of Cincinnati, Cincinnati, OH, USA
  • Yuko Y Palesch
    Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
  • Caitlyn Meinzer
    Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
  • Catherine Dillon
    Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
  • Irene Ewing
    Department of Neurology, University of Cincinnati, Cincinnati, OH, USA
  • Judith A Spilker
    Department of Neurology, University of Cincinnati, Cincinnati, OH, USA
  • Marco R Di Tullio
    Department of Medicine, Columbia University, New York, NY, USA
  • Eldad A Hod
    Department of Pathology and Cell Biology, Columbia University, New York, NY, USA
  • Elsayed Z Soliman
    Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention, and Department of Internal Medicine, Section on Cardiology, Wake Forest School of Medicine, Winston-Salem, NC, USA
  • Seemant Chaturvedi
    Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA
  • Claudia S Moy
    National Institutes of Neurological Disease and Stroke, Bethesda, MD, USA
  • Scott Janis
    National Institutes of Neurological Disease and Stroke, Bethesda, MD, USA
  • Mitchell SV Elkind
    Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA

書誌事項

公開日
2018-09-10
権利情報
  • https://journals.sagepub.com/page/policies/text-and-data-mining-license
DOI
  • 10.1177/1747493018799981
公開者
SAGE Publications

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説明

<jats:sec> <jats:title>Rationale</jats:title> <jats:p>Recent data suggest that a thrombogenic atrial substrate can cause stroke in the absence of atrial fibrillation. Such an atrial cardiopathy may explain some proportion of cryptogenic strokes.</jats:p> </jats:sec> <jats:sec> <jats:title>Aims</jats:title> <jats:p>The aim of the ARCADIA trial is to test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in subjects with cryptogenic ischemic stroke and atrial cardiopathy.</jats:p> </jats:sec> <jats:sec> <jats:title>Sample size estimate</jats:title> <jats:p>1100 participants.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and design</jats:title> <jats:p>Biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial conducted at 120 U.S. centers participating in NIH StrokeNet.</jats:p> </jats:sec> <jats:sec> <jats:title>Population studied</jats:title> <jats:p> Patients ≥ 45 years of age with embolic stroke of undetermined source and evidence of atrial cardiopathy, defined as ≥ 1 of the following markers: P-wave terminal force >5000 µV × ms in ECG lead V <jats:sub>1</jats:sub> , serum NT-proBNP > 250 pg/mL, and left atrial diameter index ≥ 3 cm/m <jats:sup>2</jats:sup> on echocardiogram. Exclusion criteria include any atrial fibrillation, a definite indication or contraindication to antiplatelet or anticoagulant therapy, or a clinically significant bleeding diathesis. Intervention: Apixaban 5 mg twice daily versus aspirin 81 mg once daily. Analysis: Survival analysis and the log-rank test will be used to compare treatment groups according to the intention-to-treat principle, including participants who require open-label anticoagulation for newly detected atrial fibrillation. </jats:p> </jats:sec> <jats:sec> <jats:title>Study outcomes</jats:title> <jats:p>The primary efficacy outcome is recurrent stroke of any type. The primary safety outcomes are symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.</jats:p> </jats:sec> <jats:sec> <jats:title>Discussion</jats:title> <jats:p>ARCADIA is the first trial to test whether anticoagulant therapy reduces stroke recurrence in patients with atrial cardiopathy but no known atrial fibrillation.</jats:p> </jats:sec>

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