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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin Treatment plus Best Medical Treatment | Experimental | Patients in this group will receive atorvastatin treatment plus best medical treatment. |
|
| Best Medical Treatment | Active Comparator | Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Treatment | Drug | Atorvastatin 20 mg once daily for 21 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 ± 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 ± 7 days |
| Ordinal distribution of mRS |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent intracerebral hemorrhage | The incidence of recurrent intracerebral hemorrhage within 90 ± 7 days | 90 ± 7 days |
| All cause mortality | All cause mortality at 90 ± 7 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Li | Contact | +8618623511778 | qili_md@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing First People's Hospital of Anhui Province | Recruiting | Anqing | Anhui | China |
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| Best Medical Treatment | Other | Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. |
|
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 |
| 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. | 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. | 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. | 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. | 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 | 7 ± 1 days |
| 90 ± 7 days |
| Any adverse event/serious adverse event | Any adverse events or serious adverse events occurred within 90 ± 7 days | 90 ± 7 days |
| Fuyang City Sixth People's Hospital | Recruiting | Fuyang | Anhui | China |
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| Fuyang Hospital of Anhui Medical University | Recruiting | Fuyang | Anhui | China |
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| Fuyang People's Hospital | Recruiting | Fuyang | Anhui | China |
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| Hefei Eighth People's Hospital | Recruiting | Hefei | Anhui | China |
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| Hefei First People's Hospital | Recruiting | Hefei | Anhui | China |
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| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| Huainan Xinhua Hospital | Recruiting | Huainan | Anhui | China |
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| The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital) | Recruiting | Huainan | Anhui | China |
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| Huoqiu First People's Hospital | Recruiting | Lu'an | Anhui | China |
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| Shucheng People's Hospital | Recruiting | Lu'an | Anhui | China |
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| Si County People's Hospital | Recruiting | Suzhou | Anhui | China |
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| The First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
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| Kaifeng Central Hospital | Recruiting | Kaifeng | Henan | China |
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| Xihua County People's Hospital | Recruiting | Zhoukou | Henan | China |
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| Xiangyang Hospital of Traditional Chinese Medicine | Recruiting | Xiangyang | Hubei | China |
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| The First People's Hospital of Chenzhou | Recruiting | Chenzhou | Hunan | China |
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| Yancheng First People's Hospital | Recruiting | Yancheng | Jiangsu | China |
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| Chengdu Western Hospital | Recruiting | Chengdu | Sichuan | China |
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| Panzhihua Central Hospital | Recruiting | Panzhihua | Sichuan | China |
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| Dazhu County People's Hospital | Recruiting | Dazhou | Sizhuan | China |
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| The Third Affiliated Hospital of Chong Qing Medical University | Recruiting | Chongqing | China |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D020300 | Intracranial Hemorrhages |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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