Actively Recruiting
Statins for Treatment Of Primary Intracerebral Hemorrhage (STOP ICH)
Led by The Second Hospital of Anhui Medical University · Updated on 2025-07-28
264
Participants Needed
22
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of atorvastatin in adults aged 18 to 80 years who have experienced spontaneous intracerebral hemorrhage (ICH) within 3 to 24 hours of symptom onset. This multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study aims to determine if atorvastatin improves clinical outcomes compared to best medical treatment alone. The study focuses on patients with hematomas located in the supratentorial region and uses the modified Rankin Scale (mRS) to measure functional outcomes at 90 days. Participants will be randomly assigned to one of two groups: one group will receive atorvastatin 20 mg once daily for 21 days along with best medical treatment (BMT) following current guidelines for ICH, while the other group will receive only BMT. The treatment period lasts for 21 days starting within 48 hours of symptom onset or last known well time. The study will monitor changes in hematoma and perihematomal edema volumes at specific time points during the first week after hemorrhage. During the trial, participants will undergo assessments including computed tomography (CT) scans to confirm ICH diagnosis and measure hematoma size, as well as evaluations using the Glasgow Coma Scale and mRS. Researchers will track functional independence and neurological outcomes at 90 ± 7 days. Safety and adverse events will be monitored throughout the study. The total follow-up includes primary and secondary outcome measurements up to three months after treatment to evaluate the impact of atorvastatin on recovery.
CONDITIONS
Brief Title
Statins for Treatment of Primary Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with spontaneous intracerebral hemorrhage confirmed by CT scan
- Age between 18 and 80 years
- Hematoma located in the supratentorial region
- Time from symptom onset or last known well to baseline CT between 3 and 24 hours
- Atorvastatin treatment can start within 48 hours of symptom onset or last known well
- Glasgow Coma Scale score of 9 or higher
- Baseline hematoma volume between 5 and 35 mL
- Signed informed consent obtained
You will not qualify if you...
- Intracerebral hemorrhage caused by trauma, tumor, aneurysm, arteriovenous malformation, vascular anomaly, hemorrhagic infarction, cerebral venous thrombosis, or related to anticoagulants
- Underwent or scheduled for immediate surgery
- Pregnant or breastfeeding
- Use of oral anticoagulants within 1 month before symptom onset
- Modified Rankin Scale score greater than 1 before stroke
- Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis
- Terminal illness with life expectancy under three months or planned withdrawal of care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 consecutive days
Participants receive best medical treatment according to guidelines. Those in the experimental group also take atorvastatin 20 mg once daily for 21 consecutive days.
Daily treatment with assessments during hospitalization
Duration - Up to 90 days
Participants are followed up to assess clinical outcomes including functional status and hematoma changes at several timepoints up to 90 days.
Visits at 24 hours, 7 days, and approximately 90 days after treatment start
Trial Site Locations
Total: 22 locations
1
Anqing First People's Hospital of Anhui Province
Anqing, Anhui, China
Actively Recruiting
2
Fuyang City Sixth People's Hospital
Fuyang, Anhui, China
Actively Recruiting
3
Fuyang Hospital of Anhui Medical University
Fuyang, Anhui, China
Actively Recruiting
4
Fuyang People's Hospital
Fuyang, Anhui, China
Actively Recruiting
5
Hefei Eighth People's Hospital
Hefei, Anhui, China
Actively Recruiting
6
Hefei First People's Hospital
Hefei, Anhui, China
Actively Recruiting
7
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
8
Huainan Xinhua Hospital
Huainan, Anhui, China
Actively Recruiting
9
The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)
Huainan, Anhui, China
Actively Recruiting
10
Huoqiu First People's Hospital
Lu'an, Anhui, China
Actively Recruiting
11
Shucheng People's Hospital
Lu'an, Anhui, China
Actively Recruiting
12
Si County People's Hospital
Suzhou, Anhui, China
Actively Recruiting
13
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
14
Kaifeng Central Hospital
Kaifeng, Henan, China
Actively Recruiting
15
Xihua County People's Hospital
Zhoukou, Henan, China
Actively Recruiting
16
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China
Actively Recruiting
17
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Actively Recruiting
18
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Actively Recruiting
19
Chengdu Western Hospital
Chengdu, Sichuan, China
Actively Recruiting
20
Panzhihua Central Hospital
Panzhihua, Sichuan, China
Actively Recruiting
21
Dazhu County People's Hospital
Dazhou, Sizhuan, China
Actively Recruiting
22
The Third Affiliated Hospital of Chong Qing Medical University
Chongqing, China
Actively Recruiting
Research Team
Q
Qi Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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