Clinical trial NCT04857632: Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
Official title: Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Intracerebral Hemorrhage
Statins
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Perihemorrhagic edema to hematoma ratio
timeFrame: 7 days
Secondary outcomes:
measure: Absolute perihematomal edema changes
timeFrame: 7 days
measure: Hematoma resolution rate
timeFrame: 7 days
measure: Absolute hematoma volume changes
timeFrame: 7 days
measure: Ordinal distribution of modified Rankin scale scores
timeFrame: 90 days
measure: Proportion of patients with modified Rankin scale score 0-2
timeFrame: 90 days
measure: Proportion of patients with modified Rankin scale score 0-3
timeFrame: 90 days
measure: Rate of mortality
timeFrame: 30 dyas
measure: National Institute of Health stroke scale
timeFrame: 7 days or discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Fengtai Youanmen Hospital
state: Beijing
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
city: Baoding
country: China
facility: Hebei Province Shunping County Hospital
Study officials:
References: