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

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT04565977
Collaborator
(none)
42
Enrollment
1
Location
11.3
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective, cohort study chart review in patients with hypercoagulable states.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational

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 Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Jun 10, 2021
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Rates of thrombotic events during the study period [Jan 1,2015 - Dec 31st, 2019]

    Rates of thrombotic events during the study period

  2. Rates of hemorrhagic events during the study period [Jan 1,2015 - Dec 31st, 2019]

    Rates of hemorrhagic events during the study period

Secondary Outcome Measures

  1. Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states [Jan 1,2015 - Dec 31st, 2019]

    Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT04565977
Other Study ID Numbers:
  • 042.PHA.2020.A
First Posted:
Sep 28, 2020
Last Update Posted:
Dec 10, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombophilia

Study Results

No Results Posted as of Dec 10, 2021