Eliquis Regulatory Post Marketing Surveillance

NonValvular Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885598
• Other study ID #: CV185-259
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: October 27, 2017
• Start date: July 10, 2013
• Est. completion date: September 29, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• NonValvular Atrial Fibrillation

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form