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Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT04153591
Collaborator
(none)
75
Enrollment
1
Location
7.6
Actual Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To describe the prescribing patterns at Methodist Dallas Medical Center (MDMC) for the treatment of newly diagnosed mural thrombus and to determine the efficacy and safety of DOACs apixaban, dabigatran, and rivaroxaban in comparison to warfarin.

With limited treatment guideline consensus, minimal evidence to support the use of DOACs for Left Atrial Appendage (LAA) thrombus and Left Ventricular Thrombus (LVT), and a lack of evidence for the use of DOACs in aortic thrombus, further research is warranted to determine the role of DOACs in the treatment of various mural thrombi in comparison to warfarin.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

    3.1. Study Methods

    • Patients will be allocated into two groups: those who were prescribed DOACs upon discharge and those who were prescribed warfarin upon discharge

    • Subgroup analyses will occur to evaluate the difference in efficacy and safety endpoints for patients into four categories including: those predisposed to mural thrombus by baseline risk factors (AFIB vs. ACS), location of the mural thrombus (atrial, ventricular, aortic), DOAC by agent (apixaban, rivaroxaban, dabigatran), and DOAC by scheduled dosing indication (AFIB vs. VTE).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus
    Actual Study Start Date :
    Nov 5, 2019
    Actual Primary Completion Date :
    Jun 22, 2020
    Actual Study Completion Date :
    Jun 22, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of the direct oral anti-coagulants [from 4/1/2017 to 8/31/19]

      Readmission for recurrent stroke or thromboembolic event within 90 days of initial hospital discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age ≥ 18 years

    2. MHS patients with newly diagnosed mural thrombus from 4/1/2017 to 8/31/19 identified by International Classification of Diseases (ICD) codes: I23.6, I240, I513, I7409, I7411, I7419, I82210, I82229

    Exclusion Criteria:

    1. Age <18 years

    2. Anticoagulant use at baseline (DOAC, LMWH, VKA)

    3. Active cancer

    4. Active bleeding

    5. Pregnancy

    6. Hospice or palliative care upon discharge

    7. Warfarin that did not receive adequate bridging from parenteral anticoagulation

    8. Non newly diagnosed mural thrombus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    • Principal Investigator: Crystal Brown, PharmD, Methodist Dallas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT04153591
    Other Study ID Numbers:
    • 058.PHA.2019.D
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Dec 13, 2021