search
Back to results

Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage (STATIC)

Primary Purpose

Intracerebral Hemorrhage, Statins

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Statin
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Fengtai Youanmen HospitalRecruiting
  • Xuan Wu Hospital，Capital Medical UniversityRecruiting
  • Hebei Province Shunping County HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Statins group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Perihemorrhagic edema to hematoma ratio

Secondary Outcome Measures

Absolute perihematomal edema changes
Hematoma resolution rate
Absolute hematoma volume changes
Ordinal distribution of modified Rankin scale scores
The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death).
Proportion of patients with modified Rankin scale score 0-2
Proportion of patients with modified Rankin scale score 0-3
Rate of mortality
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.

Full Information

First Posted
April 20, 2021
Last Updated
June 7, 2022
Sponsor
Capital Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04857632
Brief Title
Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
Acronym
STATIC
Official Title
Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Statins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statins group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
atorvastatin 20mg per day for 7 days
Primary Outcome Measure Information:
Title
Perihemorrhagic edema to hematoma ratio
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Absolute perihematomal edema changes
Time Frame
7 days
Title
Hematoma resolution rate
Time Frame
7 days
Title
Absolute hematoma volume changes
Time Frame
7 days
Title
Ordinal distribution of modified Rankin scale scores
Description
The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death).
Time Frame
90 days
Title
Proportion of patients with modified Rankin scale score 0-2
Time Frame
90 days
Title
Proportion of patients with modified Rankin scale score 0-3
Time Frame
90 days
Title
Rate of mortality
Time Frame
30 dyas
Title
National Institute of Health stroke scale
Description
Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time Frame
7 days or discharge

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Age of 18 years or older
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanjie Wu, Dr.
Phone
18911366882
Email
wuchuanjie8557@163.com
Facility Information:
Facility Name
Beijing Fengtai Youanmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daiquan Gao, M.D.
Facility Name
Xuan Wu Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xunming ji
Phone
861013120136877
Email
jixunming@vip.163.com
Facility Name
Hebei Province Shunping County Hospital
City
Baoding
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijie Bao

12. IPD Sharing Statement

Learn more about this trial

Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

We'll reach out to this number within 24 hrs