Eliquis Regulatory Post Marketing Surveillance

Bristol-Myers Squibb3,335 enrolled

Overview

The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation patients.

Study Type

OBSERVATIONAL

Enrollment

3,335

Conditions

NonValvular Atrial Fibrillation

Interventions

ApixabanDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: within 30 days after end of the treatment

Secondary Outcomes

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)

Time frame: 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)

Time frame: At 3, 6, 12, and 24 months after enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.