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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04153591

Enrollment

Registered

2019-11-06

Start date

2019-11-05

Completion date

2020-06-22

Last updated

2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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.

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results