Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

Completed

• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT01444586
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-30
• Study Start: 2011-10
• Study First Posted: 2011-10-03
• Primary Completion: 2013-08
• Study Completion: 2014-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2293

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Rivaroxaban (Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
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.	Not more than 8 weeks

Secondary Outcome Measures

Name	Time	Method
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.	Not more than 8 weeks
Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)	Not more than 8 weeks