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

NCT ID: NCT01444586

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Russia

Site Status

Countries

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Russia

Other Identifiers

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XA2011-01RU

Identifier Type: OTHER

Identifier Source: secondary_id

16002

Identifier Type: -

Identifier Source: org_study_id

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