Eliquis Regulatory Post Marketing Surveillance

October 27, 2017 updated by: Bristol-Myers Squibb

Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation

The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3335

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting outpatient department of hospital

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Patients ≥19 years of age
  • Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism
  • Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Receiving Eliquis treatment for an indication that is not approved in Korea
  • 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nonvalvular Atrial Fibrillation patients with risk of Stroke
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
Adverse events (AE) occurrence based on Incidence of serious adverse events, unexpected adverse drug reactions, Identification of AE profile in usual practice Nonserious adverse events, major bleeding
Time Frame: within 30 days after end of the treatment
within 30 days after end of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final identification of major events and no event based on Incidence of stroke, systemic embolism, death, Effectiveness or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later)
Time Frame: At 3, 6, 12, and 24 months after enrollment
Final identification of major events based on Incidence of stroke, systemic embolism, death, Effectiveness: No evidence of stroke, systemic embolism, or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later)
At 3, 6, 12, and 24 months after enrollment
Final evaluation of clinical significance of Eliquis is provided by the physician's subjective decision (Excellent, Good, Moderate, Insufficient)
Time Frame: At 3, 6, 12, and 24 months after enrollment
At 3, 6, 12, and 24 months after enrollment

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.

General Publications

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 (Actual)

July 10, 2013

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

September 29, 2017

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 (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-259

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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