Status:
RECRUITING
Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
Lead Sponsor:
Capital Medical University
Conditions:
Intracerebral Hemorrhage
Statins
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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. In...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04857632
Start Date
August 6 2021
End Date
November 30 2024
Last Update
January 23 2024
Active Locations (3)
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1
Beijing Fengtai Youanmen Hospital
Beijing, Beijing Municipality, China, 100000
2
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
Hebei Province Shunping County Hospital
Baoding, China