Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty - Full Text View

Purpose

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

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

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Knee Replacement

Drug Information available for: Rivaroxaban

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	19166
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2013
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831714

Show 42 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional 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:	Medical Affairs Therapeutic Area, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00831714 History of Changes
Other Study ID Numbers:	13802, XA0801
Study First Received:	January 28, 2009
Last Updated:	April 10, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Bosnia: Federal Ministry of Health Austria: Ethikkommission France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines Italy: Ethics Committee China: Ethics Committee Macedonia: Ministry of Health Macedonia: Ethics Committee Estonia: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Czech Republic: State Institute for Drug Control Australia: Institutional Ethics Committees Hungary: Research Ethics Medical Committee Slovakia: State Institute for Drug Control Korea: Institutional Review Board Finland: Ethics Committee Bosnia and Herzegovina: Ethics Committee Bosnia and Herzegovina: Agency for medical products and medical devices Greece: National Organization of Medicines Netherlands: Medical Ethics Review Committee (METC) Singapore: Health Sciences Authority Cyprus: Cypriot National Commitee Bioethics Portugal: Ethics Committee for Clinical Research Portugal: Health Ethic Committee United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency Sweden: Regional Ethical Review Board Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee Canada: Ethics Review Committee Colombia: Ethics Committee Venezuela: Ethics Committee, Pharmacovigilance authority (CENAVIF) Belgium: Institutional Review Board Lebanon: Institutional Review Board Switzerland: Swissmedic United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health Philippines: Bureau of Food and Drugs Serbia: Ethics Committee Mexico: Federal Commission for Sanitary Risks Protection Chile: Institutional Review Board India: Drugs Controller General of India

Keywords provided by Bayer:

Prophylaxis of Venous Thromboembolism

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 16, 2013

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