Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage (STATIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage; Statins
• Intervention / Treatment: Drug: Statin

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chuanjie Wu, Dr.; Phone Number: 18911366882; Email: wuchuanjie8557@163.com

Study Locations

• China
  • Baoding, China
    • Recruiting
    • Hebei Province Shunping County Hospital
    • Contact: Shijie Bao
  • Beijing
    • Beijing, Beijing, China, 100069
      • Recruiting
      • Xuan Wu Hospital，Capital Medical University
      • Contact: xunming ji; Phone Number: 861013120136877; Email: jixunming@vip.163.com
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Fengtai Youanmen Hospital
      • Contact: Daiquan Gao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Statins group	Drug: Statin; atorvastatin 20mg per day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perihemorrhagic edema to hematoma ratio	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute perihematomal edema changes		7 days
Hematoma resolution rate		7 days
Absolute hematoma volume changes		7 days
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
Proportion of patients with modified Rankin scale score 0-2		90 days
Proportion of patients with modified Rankin scale score 0-3		90 days
Rate of mortality		30 dyas
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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: STATIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No