NonValvular Atrial Fibrillation Clinical Trial
Official title:
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
Verified date | October 2017 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.
Status | Completed |
Enrollment | 3335 |
Est. completion date | September 29, 2017 |
Est. primary completion date | September 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Local Institution | Seoul |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | 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 | |
Secondary | 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 |
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