Clincosm LogoSign in Get a demo

A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03521908
Collaborator
(none)
35,756
Enrollment
1
Location
29.3
Actual Duration (Months)
1218.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35756 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
    Actual Study Start Date :
    Jun 13, 2016
    Actual Primary Completion Date :
    Jun 4, 2018
    Actual Study Completion Date :
    Nov 23, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Participants treated with apixaban
    Participants treated with warfarin

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of major bleeding in participants treated with apixaban [2 years]

    2. Incidence of major bleeding in participants treated with warfarin [2 years]

    Secondary Outcome Measures

    1. Incidence of clinically relevant non-major bleeding event in participants treated with apixaban [2 years]

    2. Incidence of clinically relevant non-major bleeding event in participants treated with warfarin [2 years]

    3. Incidence of recurrent VTE in participants treated with apixaban [2 years]

    4. Incidence of recurrent VTE in participants treated with warfarin [2 years]

    Eligibility Criteria

    Criteria

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

    • An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE

    • An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter

    • Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter

    Exclusion Criteria:

    • Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy

    • Evidence of VTE(VTE event)during 6-month period preceding index encounter

    • Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Princeton New Jersey United States 08540

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03521908
    Other Study ID Numbers:
    • CV185-523
    First Posted:
    May 11, 2018
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thromboembolism
    Venous Thromboembolism

    Study Results

    No Results Posted as of Feb 28, 2022