Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

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

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

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
    China

    Active - Recruiting

  • Xuan Wu Hospital,Capital Medical University

    Beijing, Beijing 100069
    China

    Active - Recruiting

  • Hebei Province Shunping County Hospital

    Baoding,
    China

    Active - Recruiting

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