Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States

November 18, 2024 updated by: Methodist Health System
Retrospective, cohort study chart review in patients with hypercoagulable states.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Retrospective, cohort study chart review in patients at Methodist Health System
  • Data will be pulled on all patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019

Description

Inclusion Criteria:

  • Patients ≥ 18 year-old
  • Patients with diagnosis of hypercoagulable state identified by ICD-9/ICD-10 codes
  • Patients who were prescribed DOACs or VKA for primary or secondary prevention of thrombosis

Exclusion Criteria:

  • Patients with FDA-approved indications of oral anticoagulants including atrial fibrillation or treatment/prevention of thrombotic events unrelated to specified hypercoagulable states
  • Patients with incomplete electronic medical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Cohort
All patients with hypercoagulable states identified by ICD-9/ICD-10 codes from January 1st, 2015 to December 31st, 2019
Other: Observational
Retrospective chart review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of thrombotic events during the study period
Time Frame: Jan 1,2015 - Dec 31st, 2019
Rates of thrombotic events during the study period
Jan 1,2015 - Dec 31st, 2019
Rates of hemorrhagic events during the study period
Time Frame: Jan 1,2015 - Dec 31st, 2019
Rates of hemorrhagic events during the study period
Jan 1,2015 - Dec 31st, 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
Time Frame: Jan 1,2015 - Dec 31st, 2019
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states
Jan 1,2015 - Dec 31st, 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Valerie Vuylsteke, PharmD, Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 10, 2021

Study Completion (Actual)

June 10, 2021

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 042.PHA.2020.A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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