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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statins group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin | Drug | atorvastatin 20mg per day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perihemorrhagic edema to hematoma ratio | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute perihematomal edema changes | 7 days | |
| Hematoma resolution rate | 7 days | |
| Absolute hematoma volume changes |
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Inclusion Criteria:
Exclusion Criteria:
Age of 18 years or older
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanjie Wu, Dr. | Contact | 18911366882 | wuchuanjie8557@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Fengtai Youanmen Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38908848 | Derived | 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. |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| 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 |
| Xuan Wu Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
|
| Hebei Province Shunping County Hospital | Recruiting | Baoding | China |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |