Hypercoagulable States Clinical Trial
Official title:
Evaluating Off-label Use of Direct Oral Anticoagulants (DOACs) in Hypercoagulable States
| NCT number | NCT04565977 |
| Other study ID # | 042.PHA.2020.A |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2020 |
| Est. completion date | June 10, 2021 |
| Verified date | December 2021 |
| Source | Methodist Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Retrospective, cohort study chart review in patients with hypercoagulable states.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | June 10, 2021 |
| Est. primary completion date | June 10, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Methodist Dallas Medical Center | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Methodist Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rates of thrombotic events during the study period | Rates of thrombotic events during the study period | Jan 1,2015 - Dec 31st, 2019 | |
| Primary | Rates of hemorrhagic events during the study period | Rates of hemorrhagic events during the study period | Jan 1,2015 - Dec 31st, 2019 | |
| Secondary | Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states | Rates of DOAC prescribing for thrombosis prevention in hypercoagulable states | Jan 1,2015 - Dec 31st, 2019 |