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Eliquis Regulatory Post Marketing Surveillance

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01885598
Collaborator
(none)
3,335
Enrollment
1
Location
50.7
Actual Duration (Months)
65.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
3335 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
Actual Study Start Date :
Jul 10, 2013
Actual Primary Completion Date :
Sep 29, 2017
Actual Study Completion Date :
Sep 29, 2017

Arms and Interventions

Arm Intervention/Treatment
Nonvalvular Atrial Fibrillation patients with risk of Stroke

Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release

Drug: Apixaban
Other Names:
  • Eliquis

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [within 30 days after end of the treatment]

    Secondary Outcome Measures

    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) [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) [At 3, 6, 12, and 24 months after enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Seoul Korea, Republic of 110-756

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01885598
    Other Study ID Numbers:
    • CV185-259
    First Posted:
    Jun 25, 2013
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Apixaban

    Study Results

    No Results Posted as of Oct 31, 2017