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

This study has been completed.
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 20, 2011
Last updated: January 19, 2017
Last verified: January 2017
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.

Condition Intervention
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 2293
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01444586

Russian Federation
Many locations, Russian Federation
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01444586     History of Changes
Other Study ID Numbers: 16002
XA2011-01RU ( Other Identifier: Company Internal )
Study First Received: September 20, 2011
Last Updated: January 19, 2017

Keywords provided by Bayer:
knee replacement
hip replecement

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on May 25, 2017