Eliquis Regulatory Post Marketing Surveillance
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
1 other identifier
observational
3,335
1 country
1
Brief Summary
The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedStudy Start
First participant enrolled
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedOctober 31, 2017
October 1, 2017
4.2 years
June 21, 2013
October 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
within 30 days after end of the treatment
Secondary Outcomes (2)
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)
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)
At 3, 6, 12, and 24 months after enrollment
Study Arms (1)
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
Interventions
Eligibility Criteria
Patients visiting outpatient department of hospital
You may qualify if:
- 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
You may not qualify if:
- Receiving Eliquis treatment for an indication that is not approved in Korea
- Contraindicated for the use of Eliquis as described in the Korean label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Seoul, 110-756, South Korea
Related Publications (1)
Kim JS, Koo J, Shin DI, Kim BS, Kim J, Kim EG, Hong KS, Yi H. Apixaban for Secondary Stroke Prevention: Coexistant Cerebral Atherosclerosis May Increase Recurrent Strokes. J Stroke. 2022 Jan;24(1):118-127. doi: 10.5853/jos.2021.02355. Epub 2022 Jan 31.
PMID: 35135065DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2013
First Posted
June 25, 2013
Study Start
July 10, 2013
Primary Completion
September 29, 2017
Study Completion
September 29, 2017
Last Updated
October 31, 2017
Record last verified: 2017-10