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 |
---|---|
Condition | NONVALVULAR ATRIAL FIBRILLATION |
Intervention | Drug: Apixaban |
Phase | N/A |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT01885598 |
First Received | June 21, 2013 |
Last Updated | October 15, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 21, 2013 |
---|---|
Last Updated Date | October 15, 2013 |
Start Date | December 2013 |
Estimated Primary Completion Date | June 2017 |
Current Primary Outcome Measures | Occurrence 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 Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Eliquis Regulatory Post Marketing Surveillance |
---|---|
Official Title | Eliquis (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 Description | Not Provided |
Study Type | Observational |
Study Phase | N/A |
Study Design | Observational Model: Case-Only, Time Perspective: Prospective |
Condition | NONVALVULAR ATRIAL FIBRILLATION |
Intervention | Drug: 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 Status | Not yet recruiting |
---|---|
Estimated Enrollment | 3000 |
Estimated Completion Date | June 2017 |
Estimated Primary Completion Date | June 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 |
Gender | Both |
Ages | 19 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01885598 |
---|---|
Other Study ID Numbers | CV185-259 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | October 2013 |