Cerebrovascular Disorders, Intracranial Hemorrhages, Intracranial Hemorrhage, Intracerebral Haemorrhage
Conditions
Keywords
Intracerebral hemorrhage, Treatment, Atorvastatin, Outcome
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.
Interventions
Atorvastatin 20 mg once daily for 21 days.
OTHERBest Medical Treatment
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Any adverse event/serious adverse event | 90 ± 7 days | Any adverse events or serious adverse events occurred within 90 ± 7 days |
| Recurrent intracerebral hemorrhage | 90 ± 7 days | The incidence of recurrent intracerebral hemorrhage within 90 ± 7 days |
| All cause mortality | 90 ± 7 days | All cause mortality at 90 ± 7 days. |
Countries
China
Contacts
Primary ContactQi Li
Outcome results
None listed