Last updated: January 19, 2024
Sponsor: Capital Medical University
Overall Status: Active - Recruiting
Phase
2/3
Condition
Brain Injury
Stroke
Hemorrhage
Treatment
Statin
Clinical Study ID
NCT04857632
STATIC
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age of 18 years or older
- A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brainCT scan
- Hematoma volume ≤40ml
- The first dose of statin can be given within 24h of intracerebral hemorrhage symptomonset (if the patient is randomized to statin group)
- Written informed consent
Exclusion
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, rupturedaneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemicinfarct, Moyamoya disease, or venous sinus thrombosis
- Unable to swallow a statin pill and have contraindication to position a nasogastrictube
- 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 thepatient'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 thepresent study
- Prior use of statins within 1 month before intracerebral hemorrhage
Study Design
Total Participants: 98
Treatment Group(s): 1
Primary Treatment: Statin
Phase: 2/3
Study Start date:
August 06, 2021
Estimated Completion Date:
November 30, 2024
Connect with a study center
Beijing Fengtai Youanmen Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing 100069
ChinaActive - Recruiting
Hebei Province Shunping County Hospital
Baoding,
ChinaActive - Recruiting

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