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A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness

Sponsor
Sanofi (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05819112
Collaborator
(none)
14,799
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE.

This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    14799 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Conventional prophylaxis

    Participants hospitalized for acute medical illness receiving conventional (i.e., once daily for 7 days) enoxaparin VTE prophylaxis
    Extended prophylaxis

    Participants hospitalized for acute medical illness receiving extended duration (i.e., once daily for 14, 21 or 28 days) enoxaparin VTE prophylaxis

    Outcome Measures

    Primary Outcome Measures

    1. Change in the incidence of VTE, from index date to Day 90 [Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.]

      VTE event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes.

    2. Change in the incidence of major bleeding, from index date to Day 90 [Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.]

      Major bleeding event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes.

    Eligibility Criteria

    Criteria

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

    • Hospitalization for the following acute conditions:

    • Infection

    • Respiratory insufficiency

    • Inflammatory condition

    • Cancer

    • Heart failure

    • Ischemic stroke

    • Initiation of enoxaparin prophylaxis during hospitalization (index date)

    • Age ≥40 years

    Exclusion Criteria:

    • Symptomatic VTE or major bleeding event 90-days prior to index date

    • Major surgery within (+1,-90) days from index date

    • Ongoing anticoagulation therapy (medication supply within [-2,-32] days from index date)

    • Atrial fibrillation

    • Chronic kidney disease (CKD) stages IV and V, or dialysis

    The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT05819112
    Other Study ID Numbers:
    • PDE0093
    • U1111-1288-8339
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 19, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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 Apr 19, 2023