Statins for Treatment of Primary Intracerebral Hemorrhage (STOP ICH)

The Second Hospital of Anhui Medical University

Status: Enrolling

Conditions: Intracerebral Haemorrhage; Intracranial Hemorrhage; Intracranial Hemorrhages; Cerebrovascular Disorders

Treatments: Other: Best Medical Treatment; Drug: Atorvastatin Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07088250

YX2023-041(F1)

Details and patient eligibility

About

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.

Full description

This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Atorvastatin Treatment plus Best Medical Treatment

Experimental group

Description:

Patients in this group will receive atorvastatin treatment plus best medical treatment.

Treatment:

Drug: Atorvastatin Treatment

Other: Best Medical Treatment

Best Medical Treatment

Active Comparator group

Description:

Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Treatment:

Other: Best Medical Treatment