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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04565977
Enrollment
42
Registered
2020-09-28
Start date
2020-07-01
Completion date
2021-06-10
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercoagulable States

Brief summary

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

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

Interventions

OTHERObservational

Retrospective chart review

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rates of thrombotic events during the study periodJan 1,2015 - Dec 31st, 2019Rates of thrombotic events during the study period
Rates of hemorrhagic events during the study periodJan 1,2015 - Dec 31st, 2019Rates of hemorrhagic events during the study period

Secondary

MeasureTime frameDescription
Rates of DOAC prescribing for thrombosis prevention in hypercoagulable statesJan 1,2015 - Dec 31st, 2019Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026