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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00831714
First received: January 28, 2009
Last updated: April 16, 2014
Last verified: April 2014
  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:


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: 19076
Study Start Date: February 2009
Study Completion Date: April 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
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, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00831714     History of Changes
Other Study ID Numbers: 13802, XA0801
Study First Received: January 28, 2009
Last Updated: April 16, 2014
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
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014