Statins for Treatment of Primary Intracerebral Hemorrhage (NCT07088250) | Clinical Trial Compass
RecruitingNot Applicable
Statins for Treatment of Primary Intracerebral Hemorrhage
China264 participantsStarted 2023-05-06
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
Poor functional outcome
Timeframe: 90 ± 7 days
Trial details
NCT IDNCT07088250
SponsorThe Second Hospital of Anhui Medical University