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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00831714




Registration number
NCT00831714
Ethics application status
Date submitted
28/01/2009
Date registered
29/01/2009
Date last updated
23/01/2017

Titles & IDs
Public title
Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty
Scientific title
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee
Secondary ID [1] 0 0
XA0801
Secondary ID [2] 0 0
13802
Universal Trial Number (UTN)
Trial acronym
XAMOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Standard care treatment for VTE prophylaxis

Group 1 -

Group 2 -


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
During observation period of three months

Eligibility
Key inclusion criteria
- Female and male patients who will undergo elective hip or knee arthroplasty.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Exclusion criteria must be read in conjunction with the local product information.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
19076
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Many Locations
Recruitment postcode(s) [1] 0 0
- Many Locations
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Many Locations
Country [2] 0 0
Belgium
State/province [2] 0 0
Many Locations
Country [3] 0 0
Bosnia and Herzegovina
State/province [3] 0 0
Many Locations
Country [4] 0 0
Brazil
State/province [4] 0 0
Many Locations
Country [5] 0 0
Canada
State/province [5] 0 0
Many Locations
Country [6] 0 0
Chile
State/province [6] 0 0
Many Locations
Country [7] 0 0
China
State/province [7] 0 0
Many Locations
Country [8] 0 0
Colombia
State/province [8] 0 0
Many Locations
Country [9] 0 0
Cyprus
State/province [9] 0 0
Many Locations
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Many Locations
Country [11] 0 0
Denmark
State/province [11] 0 0
Many Locations
Country [12] 0 0
Estonia
State/province [12] 0 0
Many Locations
Country [13] 0 0
Finland
State/province [13] 0 0
Many Locations
Country [14] 0 0
France
State/province [14] 0 0
Many Locations
Country [15] 0 0
Germany
State/province [15] 0 0
Many Locations
Country [16] 0 0
Greece
State/province [16] 0 0
Many Locations
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Many Locations
Country [18] 0 0
Hungary
State/province [18] 0 0
Many Locations
Country [19] 0 0
India
State/province [19] 0 0
Many Locations
Country [20] 0 0
Italy
State/province [20] 0 0
Many Locations
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Many Locations
Country [22] 0 0
Latvia
State/province [22] 0 0
Many Locations
Country [23] 0 0
Lebanon
State/province [23] 0 0
Many Locations
Country [24] 0 0
Lithuania
State/province [24] 0 0
Many Locations
Country [25] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [25] 0 0
Many Locations
Country [26] 0 0
Mexico
State/province [26] 0 0
Many Locations
Country [27] 0 0
Netherlands
State/province [27] 0 0
Many Locations
Country [28] 0 0
Norway
State/province [28] 0 0
Many Locations
Country [29] 0 0
Philippines
State/province [29] 0 0
Many Locations
Country [30] 0 0
Portugal
State/province [30] 0 0
Many Locations
Country [31] 0 0
Serbia
State/province [31] 0 0
Many Locations
Country [32] 0 0
Singapore
State/province [32] 0 0
Many Locations
Country [33] 0 0
Slovakia
State/province [33] 0 0
Many Locations
Country [34] 0 0
South Africa
State/province [34] 0 0
Many Locations
Country [35] 0 0
Spain
State/province [35] 0 0
Many Locations
Country [36] 0 0
Sweden
State/province [36] 0 0
Many Locations
Country [37] 0 0
Switzerland
State/province [37] 0 0
Many Locations
Country [38] 0 0
United Arab Emirates
State/province [38] 0 0
Many Locations
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Many Locations
Country [40] 0 0
Venezuela
State/province [40] 0 0
Many Locations
Country [41] 0 0
Vietnam
State/province [41] 0 0
Many Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main goal is to provide additional information to the risk-benefit assessment of the
drug.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00831714
Trial related presentations / publications
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. Epub 2013 Oct 24.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00831714