Statins for Treatment of Primary Intracerebral Hemorrhage
Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
The Second Hospital of Anhui Medical University
264 participants
May 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria7
- 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.
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Interventions
Atorvastatin 20 mg once daily for 21 days.
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07088250