Study of Atorvastatin for Treatment of Spontaneous Intracerebral Hemorrhage in Adults Aged 18 to 80

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.

Statins for Treatment of Primary Intracerebral Hemorrhage