Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT04736420
Eligibility Criteria:
Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Inclusion Criteria:
\- Confirmed acute symptomatic proximal DVT without symptomatic PE
Exclusion Criteria:
* Age ≤ 18
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment
* Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment
* Any of the following six months prior to and including day of enrollment:
* Creatine clearance \< 30 ml/min
* Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3 ULN
* Bacterial endocarditis
* Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA
* Systolic blood pressure \> 180 mgHg or diastolic blood pressure \> 110 mgHg
* Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding
* Life expectancy \< 3 months in the last year prior to and including day of enrollment
* Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment
* Symptomatic pulmonary embolism two weeks prior to and including day of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04736420
Study Brief:
Protocol Section:
NCT04736420