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

Arthroplasty, Replacement, Knee Clinical Trial

— SOPRANO  

Official title:

Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444586
• Other study ID #: 16002
• Secondary ID: XA2011-01RU
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: January 19, 2017
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2293
• Est. completion date: July 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Xarelto is indicated are fit for participation in this non-interventional study.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)		Not more than 8 weeks

External Links

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