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

January 19, 2017 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2293

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Not more than 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Not more than 8 weeks
Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)
Time Frame: Not more than 8 weeks
Not more than 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (ESTIMATE)

October 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16002
  • XA2011-01RU (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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