check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

14793

ClinicalTrials.gov Identifier:

NCT01029743

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto regulatory Post-Marketing Surveillance

Trial 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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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)

Trial summary

Enrollment Goal
3388
Trial Dates
December 2009 - January 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    From the start of signed consent to 4 weeks after discharge
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Duration of treatment
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    no

Trial design

Xarelto® regulatory Post-Marketing Surveillance
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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