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

Authors Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S

Received 19 January 2012

Accepted for publication 1 March 2012

Published 1 June 2012 Volume 2012:8 Pages 363—370

DOI https://doi.org/10.2147/VHRM.S30064

Review by Single-blind

Peer reviewer comments 2

Alexander GG Turpie,1 André C Schmidt,2 Reinhold Kreutz,3 Michael R Lassen,4 Waheed Jama,1,2 Lorenzo Mantovani,5 Sylvia Haas6
1Department of Medicine, Hamilton Health Sciences, General Division, Ontario, Canada; 2Bayer Healthcare Pharmaceuticals, Global Development, Berlin, Germany; 3Institut für Klinische Pharmakologie und Toxikologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Berlin, Germany; 4Department of Orthopaedics, Spine Clinic, Clinical Trial Unit, Hørsholm Hospital, University of Copenhagen, Hørsholm, Denmark; 5Faculty of Pharmacy, Federico II University of Naples, Naples, Italy; 6Institut für Experimentelle Onkologie und Therapieforschung, TU München, Germany

Abstract: 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.

Keywords: rivaroxaban, venous thromboembolism, effectiveness, oral anticoagulation

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