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Completed

NCT Number: NCT04153591

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • 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

  • Age <18 years
  • Anticoagulant use at baseline (DOAC, LMWH, VKA)
  • Active cancer
  • Active bleeding
  • Pregnancy
  • Hospice or palliative care upon discharge
  • Warfarin that did not receive adequate bridging from parenteral anticoagulation
  • Non newly diagnosed mural thrombus

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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