NCT04153591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

November 4, 2019

Last Update Submit

December 9, 2021

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Crystal Brown, PharmD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

November 5, 2019

Primary Completion

June 22, 2020

Study Completion

June 22, 2020

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations

US(1)