Statins for Treatment of Primary Intracerebral Hemorrhage

Not Applicable

Recruiting

• Conditions: Cerebrovascular Disorders; Intracranial Hemorrhages; Intracranial Hemorrhage; Intracerebral Haemorrhage
• Interventions: Drug: Atorvastatin Treatment; Other: Best Medical Treatment

• Registration Number: NCT07088250
• Lead Sponsor: The Second Hospital of Anhui Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-06
• Status Verified: 2025-07
• Study First Submitted: 2025-07-20
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin Treatment plus Best Medical Treatment	Atorvastatin Treatment	Patients in this group will receive atorvastatin treatment plus best medical treatment.
Atorvastatin Treatment plus Best Medical Treatment	Best Medical Treatment	Patients in this group will receive atorvastatin treatment plus best medical treatment.
Best Medical Treatment	Best Medical Treatment	Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Primary Outcome Measures

Name	Time	Method
Poor functional outcome	90 ± 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Functional independence	90 ± 7 days	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	90 ± 7 days	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	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	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.
Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days	between 24 ± 12 hours and 7 ± 1 days	Absolute and relative changes in hematoma volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan.
Changes in perihematomal edema (PHE) volume from baseline to 7 ± 1 days	7 ± 1 days	Changes in PHE volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.
Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days	7 ± 1 days	Changes in PHE volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan

Trial Locations

Locations (22)

Anqing First People's Hospital of Anhui Province; 🇨🇳 Anqing, Anhui, China

Fuyang City Sixth People's Hospital; 🇨🇳 Fuyang, Anhui, China

Fuyang Hospital of Anhui Medical University; 🇨🇳 Fuyang, Anhui, China

Fuyang People's Hospital; 🇨🇳 Fuyang, Anhui, China

Hefei Eighth People's Hospital; 🇨🇳 Hefei, Anhui, China

Hefei First People's Hospital; 🇨🇳 Hefei, Anhui, China

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Huainan Xinhua Hospital; 🇨🇳 Huainan, Anhui, China

The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital); 🇨🇳 Huainan, Anhui, China

Huoqiu First People's Hospital; 🇨🇳 Lu'an, Anhui, China

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