Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty
XAMOS
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee
2 other identifiers
observational
19,076
38 countries
38
Brief Summary
The main goal is to provide additional information to the risk-benefit assessment of the drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2009
CompletedFirst Posted
Study publicly available on registry
January 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 23, 2017
January 1, 2017
2.3 years
January 28, 2009
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality
During observation period of three months
Study Arms (2)
Group 1
Group 2
Interventions
Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for VTE prophylaxis with Rivaroxaban has been made
Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment other than rivaroxaban has been made
Eligibility Criteria
Female and male patients, who are at least 18 years of age and will undergo elective hip or knee arthroplasty, after the decision for a pharmacologic VTE prophylaxis treatment has been made
You may qualify if:
- Female and male patients who will undergo elective hip or knee arthroplasty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (42)
Unknown Facility
Many Locations, Australia
Unknown Facility
Many Locations, Austria
Unknown Facility
Many Locations, Belgium
Unknown Facility
Many Locations, Bosnia and Herzegovina
Unknown Facility
Many Locations, Brazil
Unknown Facility
Many Locations, Canada
Unknown Facility
Many Locations, Chile
Unknown Facility
Many Locations, China
Unknown Facility
Many Locations, Colombia
Unknown Facility
Many Locations, Cyprus
Unknown Facility
Many Locations, Czechia
Unknown Facility
Many Locations, Denmark
Unknown Facility
Many Locations, Estonia
Unknown Facility
Many Locations, Finland
Unknown Facility
Many Locations, France
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Greece
Unknown Facility
Many Locations, Hong Kong
Unknown Facility
Many Locations, Hungary
Unknown Facility
Many Locations, India
Unknown Facility
Many Locations, Italy
Unknown Facility
Many Locations, Latvia
Unknown Facility
Many Locations, Lebanon
Unknown Facility
Many Locations, Lithuania
Unknown Facility
Many Locations, Mexico
Unknown Facility
Many Locations, Netherlands
Unknown Facility
Many Locations, North Macedonia
Unknown Facility
Many Locations, Norway
Unknown Facility
Many Locations, Philippines
Unknown Facility
Many Locations, Portugal
Unknown Facility
Many Locations, Serbia
Unknown Facility
Many Locations, Singapore
Unknown Facility
Many Locations, Slovakia
Unknown Facility
Many Locations, South Africa
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Spain
Unknown Facility
Many Locations, Sweden
Unknown Facility
Many Locations, Switzerland
Unknown Facility
Many Locations, United Arab Emirates
Unknown Facility
Many Locations, United Kingdom
Unknown Facility
Many Locations, Venezuela
Unknown Facility
Many Locations, Vietnam
Related Publications (2)
Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.
PMID: 24154549BACKGROUNDTurpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.
PMID: 22701330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2009
First Posted
January 29, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2011
Study Completion
April 1, 2013
Last Updated
January 23, 2017
Record last verified: 2017-01