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

NCT01444586 | Completed

• 2 other identifiers: 16002XA2011-01RU
• Study Type: observational
• Target: 2,293
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Keywords

non-interventional; Xarelto; knee replacement; hip replecement; Russia

Outcome Measures

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.

  Not more than 8 weeks

Secondary Outcomes (2)

• 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.

  Not more than 8 weeks

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

  Not more than 8 weeks

Study Arms (1)

Group 1

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male and female patients ≥ 18 years old
• Elective hip or knee replacement
• Planned VTE prevention with Xarelto
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Unknown Facility

Many Locations, Russia

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 3, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: July 1, 2014
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

RU (1)