Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

Standard care treatment for VTE prophylaxis

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: XAMOS

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2013
First posted: Jan 29, 2009
Registry last updated: Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed