Intracerebral Hemorrhage, Statins
Conditions
Brief summary
Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. Statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. In preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. Clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.
Interventions
DRUGStatin
atorvastatin 20mg per day for 7 days
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perihemorrhagic edema to hematoma ratio | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma resolution rate | 7 days | — |
| Absolute hematoma volume changes | 7 days | — |
| Ordinal distribution of modified Rankin scale scores | 90 days | The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). |
| Absolute perihematomal edema changes | 7 days | — |
| Proportion of patients with modified Rankin scale score 0-3 | 90 days | — |
| Rate of mortality | 30 dyas | — |
| National Institute of Health stroke scale | 7 days or discharge | Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating more severe neurologic deficits. |
| Proportion of patients with modified Rankin scale score 0-2 | 90 days | — |
Countries
China
Contacts
Primary ContactChuanjie Wu, Dr.
Outcome results
None listed