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Completed

NCT Number: NCT01444586

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)

    Time frame: Not more than 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: SOPRANO

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 3, 2011
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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