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Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02674594
Collaborator
(none)
30,000
Enrollment
1
Duration (Months)

Study Details

Study Description

Brief Summary

The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S

Primary objective: To determine the proportions of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting

Secondary objectives:

  • To determine the cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting

  • To determine the proportions of NVAF patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Early Evaluation of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation (NVAF) Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin in the US
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Patient treated with Dabigatran
    Patient treated with Rivaroxaban
    Patient treated with Apixaban
    Patient treated with Warfarin

    Outcome Measures

    Primary Outcome Measures

    1. Proportions of NVAF patients with bleeding related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the NOACs, dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting [30 days post treatment]

    Secondary Outcome Measures

    1. The cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting [30 days post treatment]

    2. Proportions of NVAF patients with all cause hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting [30 days post treatment]

    3. Associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting [30 days post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Premier Hospital database between January 1, 2012 and December 31, 2013

    • Age 18 years or older as of initial hospitalization with AF diagnosis

    Exclusion Criteria:

    • Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS HEOR studies and is used to ensure that the study populations are NVAF patients

    • Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of new oral anticoagulants (NOACs) during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different NOAC usage groups

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT02674594
    Other Study ID Numbers:
    • CV185-405
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Apr 7, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Bristol-Myers Squibb
    Anticoagulation
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Apr 7, 2016