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

NCT ID: NCT04565977

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-06-10

Brief Summary

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

Detailed Description

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* 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

Conditions

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Hypercoagulable States

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective Cohort

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

Observational

Intervention Type OTHER

Retrospective chart review

Interventions

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Observational

Retrospective chart review

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Vuylsteke, PharmD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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042.PHA.2020.A

Identifier Type: -

Identifier Source: org_study_id

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