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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
Atorvastatin 20 mg once daily for 21 days.
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Anqing First People's Hospital of Anhui Province
Anqing, Anhui, China
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.
Time frame: 90 ± 7 days
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.
Time frame: 90 ± 7 days
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
Time frame: 90 ± 7 days
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.
Time frame: 24 ± 12 hours
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.
Time frame: 7 ± 1 days
Changes in hematoma volume from 24 ± 12 hours to 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.
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Fuyang City Sixth People's Hospital
Fuyang, Anhui, China
RECRUITINGFuyang Hospital of Anhui Medical University
Fuyang, Anhui, China
RECRUITINGFuyang People's Hospital
Fuyang, Anhui, China
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Hefei, Anhui, China
RECRUITINGHefei First People's Hospital
Hefei, Anhui, China
RECRUITINGThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGHuainan Xinhua Hospital
Huainan, Anhui, China
RECRUITINGThe First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)
Huainan, Anhui, China
RECRUITINGHuoqiu First People's Hospital
Lu'an, Anhui, China
RECRUITING...and 12 more locations
Time frame: between 24 ± 12 hours and 7 ± 1 days
Changes in perihematomal edema (PHE) volume from baseline to 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.
Time frame: 7 ± 1 days
Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days
Changes in PHE volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan
Time frame: 7 ± 1 days