Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
- Registration Number
- NCT04857632
- Lead Sponsor
- Capital Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Statins group Statin -
- Primary Outcome Measures
Name Time Method Perihemorrhagic edema to hematoma ratio 7 days
- Secondary Outcome Measures
Name Time Method 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).
Proportion of patients with modified Rankin scale score 0-2 90 days 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.
Absolute perihematomal edema changes 7 days Proportion of patients with modified Rankin scale score 0-3 90 days Rate of mortality 30 dyas Hematoma resolution rate 7 days
Trial Locations
- Locations (3)
Beijing Fengtai Youanmen Hospital
🇨🇳Beijing, Beijing, China
Xuan Wu Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Hebei Province Shunping County Hospital
🇨🇳Baoding, China