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CompletedNCT00831714XAMOSUpdated Jan 23, 2017

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

An observational study in Venous Thromboembolism, sponsored by Bayer. Completed at 42 sites in 42 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19,076
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Prophylaxis of Venous Thromboembolism
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 19,076 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19,076 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

  • Group 2

    Drug: Standard care treatment for VTE prophylaxis

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

06

What researchers measure

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

    Time frame: During observation period of three months

07

Study locations

42 sites
  • Many Locations, Australia
  • Many Locations, Austria
  • Many Locations, Belgium
  • Many Locations, Bosnia and Herzegovina
  • Many Locations, Brazil
  • Many Locations, Canada
  • Many Locations, Chile
  • Many Locations, China
  • Many Locations, Colombia
  • Many Locations, Cyprus
  • Many Locations, Czech Republic
  • Many Locations, Denmark
  • Many Locations, Estonia
  • Many Locations, Finland
  • Many Locations, France
  • Many Locations, Germany
  • Many Locations, Greece
  • Many Locations, Hong Kong
  • Many Locations, Hungary
  • Many Locations, India
  • Many Locations, Italy
  • Many Locations, Korea, Republic of
  • Many Locations, Latvia
  • Many Locations, Lebanon
  • Many Locations, Lithuania
  • Many Locations, Macedonia, The Former Yugoslav Republic of
  • Many Locations, Mexico
  • Many Locations, Netherlands
  • Many Locations, Norway
  • Many Locations, Philippines
  • Many Locations, Portugal
  • Many Locations, Serbia
  • Many Locations, Singapore
  • Many Locations, Slovakia
  • Many Locations, South Africa
  • Many Locations, Spain
  • Many Locations, Sweden
  • Many Locations, Switzerland
  • Many Locations, United Arab Emirates
  • Many Locations, United Kingdom
  • Many Locations, Venezuela
  • Many Locations, Vietnam
08

References and documents

Publications

  • 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. PubMed 24154549 ↗
  • Turpie 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. PubMed 22701330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00831714
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jan 29, 2009
Start date
Feb 2009
Primary completion
Jun 2011
Completion
Apr 2013
Last update
Jan 23, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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