check_circleStudy Completed

Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Bayer Identifier:

16002

ClinicalTrials.gov Identifier:

NCT01444586

EudraCT Number:

Not Available

EU CT Number:

Not Available
Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

Trial purpose

This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Male and female patients ≥ 18 years old
    - Elective hip or knee replacement
    - Planned VTE prevention with Xarelto
    - Written informed consent
    - The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

  • - Contraindications for the use of Xarelto in accordance with the effective instruction
    - Any reasons of medical and non-medical character, which in the opinion of the physician can hamper participation of the patient in NIS, including a potentially low compliance, impossibility of making the final visit due to distant place of residence of the patient.

Trial summary

Enrollment Goal
2293
Trial Dates
October 2011 - July 2014
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, Russia

Primary Outcome

  • Real life out-patient thromboprophylaxis after arthroplasty: Share of patients who follow physician’s prescriptions; true duration of out-patient thromboprophylaxis; duration of treatment interruptions; in case of switching - reasons, drug regimen.
    date_rangeTime Frame:
    Not more than 8 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Descriptive characteristics of prescription behaviour of orthopedists (VTE prevention recommended at discharge): continuation of rivaroxaban, switching to other products (name, dose, duration, efficacy control), mechanical prophylaxis, etc.
    date_rangeTime Frame:
    Not more than 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)
    date_rangeTime Frame:
    Not more than 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Prospective multicentre non-interventional study on compliance and patient/doctor behavior of VTE prevention in major orthopedic surgery
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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