Statins for Treatment of Primary Intracerebral Hemorrhage
Launched by THE SECOND HOSPITAL OF ANHUI MEDICAL UNIVERSITY · Jul 20, 2025
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a medication called atorvastatin (a type of statin usually used to lower cholesterol) is safe and helpful for people who have had a spontaneous bleeding stroke in the brain, known as an intracerebral hemorrhage (ICH). The trial aims to start treatment within the first two days after symptoms begin and will see if atorvastatin can improve outcomes for these patients.
People who might be eligible are adults between 18 and 80 years old who have had a confirmed bleeding stroke in a specific part of the brain and who are relatively alert (with a certain level of consciousness). The bleeding should be detected within 3 to 24 hours of when symptoms started, and the volume of bleeding should fall within a certain range. Participants will receive atorvastatin treatment soon after diagnosis and will be monitored to see how well the medication works and if it is safe. People with bleeding caused by other conditions (like injury or aneurysms), those needing immediate surgery, pregnant women, or those with certain medical issues are not eligible. If you or a family member fits these criteria, this study might be an option to consider under medical guidance.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
- • 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:
- • ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
- • 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.
About The Second Hospital Of Anhui Medical University
The Second Hospital of Anhui Medical University is a leading healthcare institution in China dedicated to advancing medical research and improving patient care. As a prominent clinical trial sponsor, the hospital is committed to conducting rigorous and innovative research that adheres to the highest ethical standards. It leverages its multidisciplinary expertise and state-of-the-art facilities to facilitate the development of new therapies and interventions, contributing significantly to the global medical community. By fostering collaboration among researchers, clinicians, and industry partners, the Second Hospital aims to translate scientific discoveries into tangible health solutions for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Harbin, Heilongjiang, China
Hefei, Anhui, China
Kaifeng, Henan, China
Panzhihua, Sichuan, China
Chenzhou, Hunan, China
Hefei, Anhui, China
Yancheng, Jiangsu, China
Fuyang, Anhui, China
Zhoukou, Henan, China
Fuyang, Anhui, China
Anqing, Anhui, China
Fuyang, Anhui, China
Hefei, Anhui, China
Huainan, Anhui, China
Huainan, Anhui, China
Lu'an, Anhui, China
Lu'an, Anhui, China
Suzhou, Anhui, China
Xiangyang, Hubei, China
Chengdu, Sichuan, China
Dazhou, Sizhuan, China
Chongqing, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported