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OC 15.2 : The SAXOPHONE Study; A Multi-Center, Multi-National Randomized Trial of Apixaban versus Standard of Care Anticoagulation for Thromboprophylaxis in Children with Congenital or Acquired Heart Disease

Researchers

Presenter

  • R. Payne

Principal Investigators

  • K. Burns

  • C. Male

  • L. Brandao

  • C. VanderPluym

  • B. Stiller

  • P. Monagle

Medical Centers

  • IU School of Medicine, Indianapolis, Indiana, United States

  • Heart Development and Structural Diseases Branch / Division of Cardiovascular Sciences, Bethesda, Maryland, United States

  • The Childrenaaas Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

  • Medical University of Vienna, Vienna, Austria, Vienna, Wien, Austria

  • Azienda Ospedaliera-Universitaria- Ospedale di S. Orsola, Bologna, Italy, Bologna, Emilia-Romagna, Italy

  • The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada, Toronto, Ontario, Canada

  • German Heart Center Munich, Technical University Munich, Munich, Bayern, Germany

  • Children’s Hospital, Harvard University, Boston, Massachusetts, United States

  • East Midlands Congenital Heart Centre, University Hospitals of Leicester NHS Trust, Leicester, England, United Kingdom

  • Children’s Healthcare of Atlanta and Emory University, School of Medicine, Department of Pediatrics, Atlanta, Georgia, United States

  • Department of Congenital Heart Defects and Pediatric Cardiology, University Heart Center Freiburg-BadKrozingen, University of Freiburg, Freiburg-BadKrozingen, Baden-Wurttemberg, Germany

  • 12Department of Neurology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA Cincinnati OH United States

  • Departamento de Cardiología Pedíatrica, Instituto Nacional de Cardiología, Mexico City, Distrito Federal, Mexico

  • New Children's Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland

  • HealthCore, Wilmington, Delaware, United States

  • Bristol Myers Squibb, Inc., Lawrence Township, New Jersey, United States

  • Bristol Myers Squibb, Inc., Lawrence Township, New Jersey, United States

  • Dept of Paediatrics, Univ of Melbourne, and Royal Children's Hospital, Melbourne, Victoria, Australia

Locations

  • United States

  • Austria

  • Italy

  • Canada

  • Germany

  • United Kingdom

  • Mexico

  • Finland

  • Australia

Companies

  • N/A

Study Components

Therapeutic Area

  • N/A

Disease

  • N/A

Biomarkers

  • N/A

Drug/Treatment

  • apixaban

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Pharmacodynamics

  • Double Blind/Blinded

  • Open Label

  • Multicenteric

Phase

  • II

Study Id's

  • N/A

Sponsors

  • Bristol Myers Squibb and Pfizer

Result

  • N/A

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