check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

13802

ClinicalTrials.gov Identifier:

NCT00831714

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto for VTE prophylaxis after hip or knee arthroplasty

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A


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


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

Trial summary

Enrollment Goal
19076
Trial Dates
February 2009 - April 2013
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Completed
Many Locations, Italy
Completed
Many Locations, Canada
Completed
Many Locations, Sweden
Completed
Many Locations, Portugal
Completed
Many Locations, Hungary
Completed
Many Locations, Greece
Completed
Many Locations, Slovakia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Hong Kong
Completed
Many Locations, Singapore
Completed
Many Locations, Latvia
Completed
Many Locations, Macedonia
Completed
Many Locations, Mexico
Completed
Many Locations, Spain
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Denmark
Completed
Many Locations, Czech Republic
Completed
Many Locations, Australia
Completed
Many Locations, Austria
Completed
Many Locations, China
Completed
Many Locations, Lithuania
Completed
Many Locations, Finland
Completed
Many Locations, Venezuela
Terminated
Many Locations, Estonia
Completed
Many Locations, Serbia
Completed
Many Locations, Cyprus
Terminated
Many Locations, South Africa
Completed
Many Locations, Norway
Completed
Many Locations, Chile
Completed
Many Locations, Colombia
Terminated
Many Locations, Brazil
Completed
Many Locations, Bosnia And Herzegovina
Completed
Many Locations, Lebanon
Completed
Many Locations, Philippines
Completed
Many Locations, Switzerland
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, India
Completed
Many Locations, Vietnam

Primary Outcome

  • 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
    date_rangeTime Frame:
    During observation period of three months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Xarelto in the prophylaxis of post surgical venous thromboembolism after elective major orthopedic surgery of hip or knee
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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