Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Venous Thromboembolism Clinical Trial

— XAMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831714
• Other study ID #: 13802
• Secondary ID: XA0801
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: January 19, 2017
• Start date: February 2009
• Est. completion date: April 2013

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19076
• Est. completion date: April 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		During observation period of three months

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