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Eliquis Regulatory Post Marketing Surveillance (rPMS)

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ClinicalTrials.gov Identifier: NCT01885585
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Apixaban

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

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 Name: Eliquis




Primary Outcome Measures :
  1. Number of Adverse Events (AEs) and serious AEs [ Time Frame: Up to 30 days after last study drug dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885585


Locations
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Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01885585    
Other Study ID Numbers: CV185-222
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants