Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage (STATIC)

C

Capital Medical University

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Statins
Intracerebral Hemorrhage

Treatments

Drug: Statin

Study type

Interventional

Funder types

Other

Identifiers

NCT04857632
STATIC

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

Statins group
Experimental group
Treatment:
Drug: Statin
Control group
No Intervention group

Trial contacts and locations

0

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Central trial contact

Chuanjie Wu, Dr.

Data sourced from clinicaltrials.gov

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