Xarelto Regulatory Post-Marketing Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01029743
First received: December 9, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® Regulatory Post-Marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse event collection [ Time Frame: From the start of signed consent to 4 weeks after discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of treatment [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Estimated Enrollment: 4000
Study Start Date: December 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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

Criteria

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)
  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: NCT01029743

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Korea, Republic of
Recruiting
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01029743     History of Changes
Other Study ID Numbers: 14793, XA0910KR
Study First Received: December 9, 2009
Last Updated: August 26, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Rivaroxaban
Fondaparinux
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014