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Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00831714
Acronym
XAMOS
Enrollment
19076
Registered
2009-01-29
Start date
2009-02-28
Completion date
2013-04-30
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Prophylaxis of Venous Thromboembolism

Brief summary

The main goal is to provide additional information to the risk-benefit assessment of the drug.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

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

DRUGStandard care treatment for VTE prophylaxis

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

Sponsors

Janssen Research & Development, LLC
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female and male patients who will undergo elective hip or knee arthroplasty.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
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 mortalityDuring observation period of three months

Countries

Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Latvia, Lebanon, Lithuania, Mexico, Netherlands, North Macedonia, Norway, Philippines, Portugal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Venezuela, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026