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Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05471505
Collaborator
(none)
46,000
Enrollment
29
Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

  • The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.

  • Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.

  • An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.

  • Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.

  • Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).

  • This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    46000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.
    Anticipated Study Start Date :
    Jul 21, 2022
    Anticipated Primary Completion Date :
    Jul 25, 2022
    Anticipated Study Completion Date :
    Aug 19, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Time to incidence of a composite stroke and systemic embolism [Maximum of 14 years (from 2008 to 2021)]

    2. Time to incidence of Major bleeding events [Maximum of 14 years (from 2008 to 2021)]

      Major bleeding is defined as any bleeding requiring hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.

    • Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort

    • No use of the any oral anticoagulants (OACs) during the baseline period (the 180 days before the index date)

    • Age of 18 years or older on the index date

    Exclusion Criteria:

    • Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period

    • Having a procedure of prosthetic heart valve during the baseline period

    • Having a cardiac surgery procedure record during the baseline period

    • Having a diagnosis of venous thromboembolism during the baseline period

    • Having a hemodialysis during the baseline period

    • Female patients with pregnancy during the baseline and follow-up period

    • Patients prescribed apixaban other than approved daily dose (<5 mg or >10 mg)

    • Patients prescribed OACs during baseline period

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05471505
    Other Study ID Numbers:
    • B0661178
    First Posted:
    Jul 22, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 22, 2022