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

• ClinicalTrials.gov Identifier: NCT00831714
• Recruitment Status: Completed
• First Posted: January 29, 2009
• Last Update Posted: January 23, 2017
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: Bayer Study Director; Bayer

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00831714
• Other Study ID Numbers: 13802; XA0801 ( Other Identifier: company internal )
• First Posted: January 29, 2009
• Last Update Posted: January 23, 2017
• Last Verified: January 2017

Keywords provided by Bayer:

Prophylaxis of Venous Thromboembolism

Additional relevant 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