Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus
NCT ID: NCT04153591
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2019-11-05
2020-06-22
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Crystal Brown, PharmD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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058.PHA.2019.D
Identifier Type: -
Identifier Source: org_study_id