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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT04857632
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 years or older
* A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan
* Hematoma volume ≤40ml
* The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)
* Written informed consent
Exclusion Criteria:
* Presence of intraventricular hemorrhage or subarachnoid hemorrhage
* Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)
* Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis
* Unable to swallow a statin pill and have contraindication to position a nasogastric tube
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal
* Known pregnancy, or positive pregnancy test, or breastfeeding
* Other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study
* Historical modified Rankin scale score ≥2
* Life expectancy of less than 7 days
* Participation in another clinical study within 30 days prior to screening for the present study
* Prior use of statins within 1 month before intracerebral hemorrhage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04857632
Study Brief:
Protocol Section:
NCT04857632