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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT04229758
Eligibility Criteria:
Inclusion Criteria:
Entry into the trial is primarily driven pragmatically by clinician intent to restart a Direct Oral Anticoagulant (DOAC) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.
1. Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE) or both (2,500 patients per year at our 40 sites)
2. Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of \> 3 (at least 3 of the following risk factors: age greater than 65,( age \> 75 counts for two points), history of stroke or TIA, history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female gender, history of hypertension) (Excludes 20% or 500 patients per year)
Exclusion Criteria:
1. Mechanical Valve
2. Ventricular Assist Device (VAD)
3. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
4. Physician plan to start/restart antiplatelet therapy during trial period
5. Acute Injury Score other than head \>=3
6. Pregnancy
7. Inability to understand need for adherence to study protocol
8. Renal function below DOAC label exclusions
9. Any active pathological bleeding (e.g. no acute blood on most recent CT)
10. Hypersensitivity to drug or other label contraindication
11. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
12. Expected completion of DOAC therapy expected prior to 60 day primary outcome, e.g. 3-6 month VTE therapy
13. Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04229758
Study Brief:
Protocol Section:
NCT04229758