Xarelto Regulatory Post-Marketing Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029743
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : January 23, 2017
Janssen Research & Development, LLC
Information provided by (Responsible Party):

Brief Summary:

This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).

  1. Known and unknown adverse reactions, especially serious adverse reactions
  2. Incidence of adverse reactions under the routine drug use
  3. Factors that may affect the safety of the drug
  4. Factors that may affect the effectiveness of the drug
  5. Other safety information related to overuse, drug interaction and laboratory abnormalities
  6. Other adverse reactions

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)

Study Type : Observational
Actual Enrollment : 3388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® Regulatory Post-Marketing Surveillance
Study Start Date : December 2009
Actual Primary Completion Date : March 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Daily dose, a treatment duration of 5 weeks for patients undergoing major hip surgery and a treatment duration of 2 weeks for patients undergoing major knee surgery are recommended
Group 2 Drug: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
Daily dose, dosage frequency and duration will be decided by physicians

Primary Outcome Measures :
  1. Adverse event collection [ Time Frame: From the start of signed consent to 4 weeks after discharge ]

Secondary Outcome Measures :
  1. Duration of treatment [ Time Frame: Whole treatment period ]

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will be treated with rivaroxaban or other pharmacologic agents (e.g. LMWH/VKA/Fondaparinux) to prevent VTE after elective total hip replacement or total knee replacement

Inclusion Criteria:

  • Female and male patients >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study

Exclusion Criteria:

  • Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
  • Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
  • Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
  • Pregnant or lactating women
  • Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029743

Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01029743     History of Changes
Other Study ID Numbers: 14793
XA0910KR ( Other Identifier: company internal )
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Bayer:
TKR (Total Knee Replacement)
THR (Total Hip Replacement)
VTE (Venous Thromboembolism)
LMWH (Low Molecular Weight Heparin)
VKA (Vitamin K antagonist)

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents