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Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery

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  • Alexander G G Turpie
  • André C Schmidt
  • Reinhold Kreutz
  • Michael Rud-Lassen
  • Waheed Jamal
  • Lorenzo Mantovani
  • Sylvia Haas
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Venous thromboembolism is a frequent and potentially life-threatening complication of orthopedic surgery. Rivaroxaban is an oral direct factor Xa inhibitor, which was shown to be effective for the prevention of venous thromboembolism after elective hip and knee arthroplasty in the RECORD study program. Rivaroxaban has the potential to overcome the limitations of the current standards of care in the prevention of venous thromboembolism. XAMOS (Xarelto(®) in the prophylaxis of post-surgical venous thromboembolism after elective major orthopedic surgery of hip or knee) is an international, noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers worldwide, with about 7500 patients receiving rivaroxaban and about 7500 standard of care. XAMOS will supplement the clinical data obtained in the Phase III RECORD 1, 2, 3, and 4 trials in which rivaroxaban was shown to be superior for the primary efficacy endpoints, and with a safety profile similar to that of enoxaparin after hip or knee replacement surgery. XAMOS was started in 2009 and will complete recruitment and follow-up in 2011.
Original languageEnglish
JournalVascular Health and Risk Management (Online)
Volume8
Pages (from-to)363-70
Number of pages8
ISSN1178-2048
DOIs
Publication statusPublished - 2012

    Research areas

  • Anticoagulants, Hemorrhage, Hip Joint, Humans, Knee Joint, Morpholines, Orthopedic Procedures, Registries, Research Design, Thiophenes, Time Factors, Treatment Outcome, Venous Thromboembolism

ID: 36768917