Eliquis Regulatory Post Marketing Surveillance

Active, not recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Apixaban Drug
    Other Names: BMS-562247
    ARM 1: Kind: Experimental
    Label: Nonvalvular Atrial Fibrillation patients with risk of Stroke
    Description: Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients visiting outpatient department of hospital

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of stroke, systemic embolism and death At each visit (3, 6, 12 and 24 months) Yes
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 Yes
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) At 3, 6, 12, and 24 months after enrollment No
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 No
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 Yes

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