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

December 9, 2021 updated by: Methodist Health System

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the direct oral anti-coagulants
Time Frame: from 4/1/2017 to 8/31/19
Readmission for recurrent stroke or thromboembolic event within 90 days of initial hospital discharge
from 4/1/2017 to 8/31/19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Actual)

June 22, 2020

Study Completion (Actual)

June 22, 2020

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 058.PHA.2019.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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