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.
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;
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;
Parallel
Atorvastatin Treatment
DrugAtorvastatin 20 mg once daily for 21 days.
Best Medical Treatment
Other interventionPatients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Poor functional outcome
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.
Functional independence
The proportion of functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 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.
Ordinal distribution of mRS
Ordinal distribution of the modified Rankin Scale (mRS) 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
Changes in hematoma volume from baseline to 24 ± 12 hours
Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 24 ± 12 hours post-baseline.
Changes in hematoma volume from baseline to 7 ± 1 days
Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.
Recurrent intracerebral hemorrhage
The incidence of recurrent intracerebral hemorrhage within 90 ± 7 days
All cause mortality
All cause mortality at 90 ± 7 days.
Any adverse event/serious adverse event
Any adverse events or serious adverse events occurred within 90 ± 7 days
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