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Recruiting NCT07088250

Statins for Treatment of Primary Intracerebral Hemorrhage

Trial Parameters

Condition Cerebrovascular Disorders
Sponsor The Second Hospital of Anhui Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 264
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-05-06
Completion 2026-09-30
Interventions
Atorvastatin TreatmentBest Medical Treatment

Brief 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 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;

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