Back to Journals » Vascular Health and Risk Management » Volume 8

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

Authors Turpie A, Schmidt, Kreutz R, Lassen M, Jamal, Mantovani, Haas S

Received 19 January 2012

Accepted for publication 1 March 2012

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


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

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]


Other articles by this author:

Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice

Bramlage P, Fronk EM, Wolf WP, Smolnik R, Sutton G, Schmieder RE

Vascular Health and Risk Management 2015, 11:1-8

Published Date: 17 December 2014

Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010

Bramlage P, Deutsch C, Krüger R, Wolf A, Müller P, Zwingers T, Beime B, Mengden T

Vascular Health and Risk Management 2014, 10:303-309

Published Date: 13 May 2014

Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice

Bramlage P, Zemmrich C, Ketelhut R, Wolf WP, Fronk EM, Schmieder RE

Vascular Health and Risk Management 2013, 9:475-483

Published Date: 26 August 2013

Diabetes prevalence and metabolic risk profile in an unselected population visiting pharmacies in Switzerland

Rey A, Thoenes M, Fimmers R, Meier CA, Bramlage P

Vascular Health and Risk Management 2012, 8:541-547

Published Date: 21 September 2012

Barriers to cardiovascular risk prevention and management in Germany – an analysis of the EURIKA study

Schmieder RE, Goebel M, Bramlage P

Vascular Health and Risk Management 2012, 8:177-186

Published Date: 15 March 2012

Effectiveness and tolerability of a fixed-dose combination of olmesartan and amlodipine in clinical practice

Peter Bramlage, Wolf-Peter Wolf, Thomas Stuhr, et al

Vascular Health and Risk Management 2010, 6:803-811

Published Date: 27 August 2010

Readers of this article also read:

BRAF mutation as a biomarker in colorectal cancer

Varghese AM, Saltz LB

Advances in Genomics and Genetics 2015, 5:347-353

Published Date: 15 October 2015

Skull base metastasis from papillary thyroid carcinoma: a report of three cases

Tunio MA, Al Asiri M, Al-Qahtani KH, Aldandan S, Riaz K, Bayoumi Y

International Medical Case Reports Journal 2015, 8:127-131

Published Date: 25 June 2015

Tracking the 2015 Gastrointestinal Cancers Symposium: bridging cancer biology to clinical gastrointestinal oncology

Aprile G, Leone F, Giampieri R, Casagrande M, Marino D, Faloppi L, Cascinu S, Fasola G, Scartozzi M

OncoTargets and Therapy 2015, 8:1149-1156

Published Date: 22 May 2015

Cancer patient-centered home care: a new model for health care in oncology

Tralongo P, Ferraù F, Borsellino N, Verderame F, Caruso M, Giuffrida D, Butera A, Gebbia V

Therapeutics and Clinical Risk Management 2011, 7:387-392

Published Date: 9 September 2011

Multidisciplinary care in pediatric oncology

Cantrell MA, Ruble K

Journal of Multidisciplinary Healthcare 2011, 4:171-181

Published Date: 30 May 2011

Pegylated liposomal doxorubicin in the management of ovarian cancer

Gabriella Ferrandina, Giacomo Corrado, Angelo Licameli, et al

Therapeutics and Clinical Risk Management 2010, 6:463-483

Published Date: 29 September 2010

Use of electronic medical records in oncology outcomes research

Gena Kanas, Libby Morimoto, Fionna Mowat, et al

ClinicoEconomics and Outcomes Research 2010, 2:1-14

Published Date: 24 February 2010