Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty (XAMOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00831714
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Standard care treatment for VTE prophylaxis

Layout table for study information
Study Type : Observational
Actual Enrollment : 19076 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee
Study Start Date : February 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Group 1 Drug: Rivaroxaban (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

Group 2 Drug: Standard 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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831714


Locations
Layout table for location information
Australia
Many Locations, Australia
Austria
Many Locations, Austria
Belgium
Many Locations, Belgium
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Brazil
Many Locations, Brazil
Canada
Many Locations, Canada
Chile
Many Locations, Chile
China
Many Locations, China
Colombia
Many Locations, Colombia
Cyprus
Many Locations, Cyprus
Czech Republic
Many Locations, Czech Republic
Denmark
Many Locations, Denmark
Estonia
Many Locations, Estonia
Finland
Many Locations, Finland
France
Many Locations, France
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Hong Kong
Many Locations, Hong Kong
Hungary
Many Locations, Hungary
India
Many Locations, India
Italy
Many Locations, Italy
Korea, Republic of
Many Locations, Korea, Republic of
Latvia
Many Locations, Latvia
Lebanon
Many Locations, Lebanon
Lithuania
Many Locations, Lithuania
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Mexico
Many Locations, Mexico
Netherlands
Many Locations, Netherlands
Norway
Many Locations, Norway
Philippines
Many Locations, Philippines
Portugal
Many Locations, Portugal
Serbia
Many Locations, Serbia
Singapore
Many Locations, Singapore
Slovakia
Many Locations, Slovakia
South Africa
Many Locations, South Africa
Spain
Many Locations, Spain
Sweden
Many Locations, Sweden
Switzerland
Many Locations, Switzerland
United Arab Emirates
Many Locations, United Arab Emirates
United Kingdom
Many Locations, United Kingdom
Venezuela
Many Locations, Venezuela
Vietnam
Many Locations, Vietnam
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00831714    
Other Study ID Numbers: 13802
XA0801 ( Other Identifier: company internal )
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Keywords provided by Bayer:
Prophylaxis of Venous Thromboembolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants