Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

NCT04857632 | Unknown Phase 2

• 1 other identifier: STATIC
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Intracerebral Hemorrhage; Statins

Outcome Measures

Primary Outcomes (1)

• Perihemorrhagic edema to hematoma ratio

  7 days

Secondary Outcomes (8)

• Absolute perihematomal edema changes

  7 days

• Hematoma resolution rate

  7 days

• Absolute hematoma volume changes

  7 days

• Ordinal distribution of modified Rankin scale scores

  90 days

• Proportion of patients with modified Rankin scale score 0-2

  90 days

Study Arms (2)

Statins group

EXPERIMENTAL

Drug: Statin

Control group

NO INTERVENTION

Interventions

Statin DRUG

atorvastatin 20mg per day for 7 days

Statins group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Age of 18 years or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (3)

Beijing Fengtai Youanmen Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

Hebei Province Shunping County Hospital

Baoding, China

RECRUITING

Related Publications (1)

• Gao D, Chu X, Zhang Y, Yan H, Niu L, Jiang X, Bao S, Ji X, Wu C. Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial. BMJ Open. 2024 Jun 21;14(6):e079879. doi: 10.1136/bmjopen-2023-079879.

  PMID: 38908848 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Central Study Contacts

Chuanjie Wu, Dr.

CONTACT

18911366882; wuchuanjie8557@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: August 6, 2021
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)