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Recruiting Not applicable

Statins for Treatment of Primary Intracerebral Hemorrhage

NCT07088250 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-05-06
Last updated
2025-07-28

Condition(s) studied

Cerebrovascular DisordersIntracranial HemorrhagesIntracranial HemorrhageIntracerebral Haemorrhage

Investigational drug(s) / intervention(s)

Atorvastatin TreatmentBest 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.

Study summary

The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Poor functional outcome — 90 ± 7 days
    The proportion of poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.

Trial sites (22)

FacilityCityRegionStatus
Anqing First People's Hospital of Anhui Province Anqing Anhui Recruiting
Fuyang City Sixth People's Hospital Fuyang Anhui Recruiting
Fuyang Hospital of Anhui Medical University Fuyang Anhui Recruiting
Fuyang People's Hospital Fuyang Anhui Recruiting
Hefei Eighth People's Hospital Hefei Anhui Recruiting
Hefei First People's Hospital Hefei Anhui Recruiting
The Second Hospital of Anhui Medical University Hefei Anhui Recruiting
Huainan Xinhua Hospital Huainan Anhui Recruiting
The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital) Huainan Anhui Recruiting
Huoqiu First People's Hospital Lu'an Anhui Recruiting
Shucheng People's Hospital Lu'an Anhui Recruiting
Si County People's Hospital Suzhou Anhui Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
Kaifeng Central Hospital Kaifeng Henan Recruiting
Xihua County People's Hospital Zhoukou Henan Recruiting
Xiangyang Hospital of Traditional Chinese Medicine Xiangyang Hubei Recruiting
The First People's Hospital of Chenzhou Chenzhou Hunan Recruiting
Yancheng First People's Hospital Yancheng Jiangsu Recruiting
Chengdu Western Hospital Chengdu Sichuan Recruiting
Panzhihua Central Hospital Panzhihua Sichuan Recruiting
Dazhu County People's Hospital Dazhou Sizhuan Recruiting
The Third Affiliated Hospital of Chong Qing Medical University Chongqing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07088250 on ClinicalTrials.gov ↗ ← All trials in China