NonValvular Atrial Fibrillation
Conditions
Brief summary
The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.
Interventions
DRUGApixaban
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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 | within 30 days after end of the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 | — |
Countries
South Korea
Outcome results
None listed