Eliquis Regulatory Post Marketing Surveillance (rPMS)

February 5, 2016 updated by: Bristol-Myers Squibb

Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic Patients must be ≥19 years of age, at risk for venous thrombosis, and have elected to undergo total hip replacement arthroplasty or total knee replacement arthroplasty will be included in this study

Description

Inclusion Criteria:

  • Signed data release
  • Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion Criteria:

  • Being treated for an indication not approved for the use of Eliquis® in Korea
  • Is contraindicated for the use of Eliquis® as described in the Korean label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with risk of VTE
Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release
Drug: Apixaban
Other Names:
  • Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events (AEs) and serious AEs
Time Frame: Up to 30 days after last study drug dose
Up to 30 days after last study drug dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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