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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01444586
First received: September 20, 2011
Last updated: September 26, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 2345
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01444586     History of Changes
Other Study ID Numbers: 16002, XA2011-01RU
Study First Received: September 20, 2011
Last Updated: September 26, 2014
Health Authority: Russian Federation: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 20, 2014