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

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT04153591
• Lead Sponsor: Methodist Health System

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).

Study Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study Start: 2019-11-05
• Study First Posted: 2019-11-06
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States