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OpenTrials
Completed

NCT Number: NCT01885598

Eliquis Regulatory Post Marketing Surveillance

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

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Key information

Conditions

NonValvular Atrial Fibrillation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, 110-756, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Other names: Eliquis

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

    Time frame: within 30 days after end of the treatment

Secondary outcomes

  1. 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)

    Time frame: 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 25, 2013
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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