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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01444586
First received: September 20, 2011
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  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.


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:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome) [ Time Frame: Not more than 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2522
Study Start Date: October 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444586

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Russian Federation
Recruiting
Many locations, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, ZAO BAYER
ClinicalTrials.gov Identifier: NCT01444586     History of Changes
Other Study ID Numbers: 16002, XA2011-01RU
Study First Received: September 20, 2011
Last Updated: May 28, 2013
Health Authority: Russian Federation: Ethics Committee

Keywords provided by Bayer:
non-interventional
Xarelto
knee replacement
hip replecement
Russia

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on June 17, 2013