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

Bayer0 sites19,076 target enrollmentFebruary 2009

ConditionsVenous Thromboembolism

InterventionsRivaroxaban (Xarelto, BAY59-7939)Standard care treatment for VTE prophylaxis

DrugsRivaroxaban (Xarelto, BAY59-7939)Standard care treatment for VTE prophylaxis

Overview

Phase: Not Applicable
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Venous Thromboembolism
Sponsor: Bayer
Enrollment: 19076
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

April 2013

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Group 1

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Group 2

Intervention: Standard care treatment for VTE prophylaxis

Outcomes

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