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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153591
• Other study ID #: 058.PHA.2019.D
• Status: Completed
• Start date: November 5, 2019
• Est. completion date: June 22, 2020

Study information

• Verified date: December 2021
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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