Statins for Treatment of Primary Intracerebral Hemorrhage
NCT ID: NCT07088250
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2023-05-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Atorvastatin Treatment plus Best Medical Treatment
Patients in this group will receive atorvastatin treatment plus best medical treatment.
Atorvastatin Treatment
Atorvastatin 20 mg once daily for 21 days.
Best Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Best Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Best Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Interventions
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Atorvastatin Treatment
Atorvastatin 20 mg once daily for 21 days.
Best Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Eligibility Criteria
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Inclusion Criteria
* Age 18-80 years;
* Hematoma located in the supratentorial region;
* Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
* Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
* Glasgow Coma Scale (GCS) score ≥9;
* Baseline hematoma volume of 5-35 mL;
* Signed informed consent obtained.
Exclusion Criteria
* Patients who have undergone or are scheduled for immediate surgical intervention;
* Pregnancy or lactation;
* Use of oral anticoagulants within 1 month prior to symptom onset;
* Pre-stroke mRS \>1;
* Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;
* Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.
18 Years
80 Years
ALL
No
Sponsors
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The Second Hospital of Anhui Medical University
OTHER
Responsible Party
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Qi Li
Professor
Locations
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Anqing First People's Hospital of Anhui Province
Anqing, Anhui, China
Fuyang City Sixth People's Hospital
Fuyang, Anhui, China
Fuyang Hospital of Anhui Medical University
Fuyang, Anhui, China
Fuyang People's Hospital
Fuyang, Anhui, China
Hefei Eighth People's Hospital
Hefei, Anhui, China
Hefei First People's Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Huainan Xinhua Hospital
Huainan, Anhui, China
The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)
Huainan, Anhui, China
Huoqiu First People's Hospital
Lu'an, Anhui, China
Shucheng People's Hospital
Lu'an, Anhui, China
Si County People's Hospital
Suzhou, Anhui, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Xihua County People's Hospital
Zhoukou, Henan, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Chengdu Western Hospital
Chengdu, Sichuan, China
Panzhihua Central Hospital
Panzhihua, Sichuan, China
Dazhu County People's Hospital
Dazhou, Sizhuan, China
The Third Affiliated Hospital of Chong Qing Medical University
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YX2023-041(F1)
Identifier Type: -
Identifier Source: org_study_id
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