Study 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

Inclusion Criteria
- 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.
Exclusion Criteria
- 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

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
Time Frame:
Not more than 8 weeks
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.
Time Frame:
Not more than 8 weeks
Safety Issue:
No
Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)
Time Frame:
Not more than 8 weeks
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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results posting provided by Bayer.