Eliquis Regulatory Post Marketing Surveillance

Overview[ - collapse ][ - ]

Purpose 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
ConditionNONVALVULAR ATRIAL FIBRILLATION
InterventionDrug: Apixaban
PhaseN/A
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT01885598
First ReceivedJune 21, 2013
Last UpdatedOctober 15, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 21, 2013
Last Updated DateOctober 15, 2013
Start DateDecember 2013
Estimated Primary Completion DateJune 2017
Current Primary Outcome MeasuresOccurrence of stroke, systemic embolism and death [Time Frame: At each visit (3, 6, 12 and 24 months)] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEliquis Regulatory Post Marketing Surveillance
Official TitleEliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
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
Detailed DescriptionNot Provided
Study TypeObservational
Study PhaseN/A
Study DesignObservational Model: Case-Only, Time Perspective: Prospective
ConditionNONVALVULAR ATRIAL FIBRILLATION
InterventionDrug: Apixaban
Other Names:
Eliquis
Study Arm (s)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

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment3000
Estimated Completion DateJune 2017
Estimated Primary Completion DateJune 2017
Eligibility Criteria
Inclusion Criteria:

- ≥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
GenderBoth
Ages19 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01885598
Other Study ID NumbersCV185-259
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateOctober 2013