Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— STATIC  

Official title:

Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857632
• Other study ID #: STATIC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 6, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Capital Medical University
• Contact: Chuanjie Wu, Dr.
• Phone: 18911366882
• Email: wuchuanjie8557[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Statins

Intervention

Drug:
• Statin
atorvastatin 20mg per day for 7 days

Locations

Country	Name	City	State
China	Hebei Province Shunping County Hospital	Baoding
China	Beijing Fengtai Youanmen Hospital	Beijing	Beijing
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perihemorrhagic edema to hematoma ratio		7 days
Secondary	Absolute perihematomal edema changes		7 days
Secondary	Hematoma resolution rate		7 days
Secondary	Absolute hematoma volume changes		7 days
Secondary	Ordinal distribution of modified Rankin scale scores	The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death).	90 days
Secondary	Proportion of patients with modified Rankin scale score 0-2		90 days
Secondary	Proportion of patients with modified Rankin scale score 0-3		90 days
Secondary	Rate of mortality		30 dyas
Secondary	National Institute of Health stroke scale	Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating more severe neurologic deficits.	7 days or discharge