Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

Detailed Description
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This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

Official Title
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Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke

Conditions
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Ischemic

Intervention / Treatment
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* Drug: Rosuvastatin
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45 to 75 years old patients; Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences; Time from symptom onset to take the study assigned medication is within 24 hours; Statin naïve or discontinued at least 3 month before stroke onset; First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event; Moderate neurological deficit with baseline NIHSS scoring from 4-20; MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset; Consent form signed. Exclusion Criteria: - Any of the following is regarded as a criterion for exclusion from the study: Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences; Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study; Any circumstances under which MRI scans can't be performed; Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc; Comatose with NIHSS 1a>1; Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse; Suitable for rt-Plasminogen Activator thrombolysis treatment; Receiving medication with possible neuroprotective functions after stroke onset; Currently take steroids therapy; Diagnosed with malignancy within 5 years; Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury; Severe renal function damage (eGFR<30); Concurrent use ciclosporin; A history of hypersensitivity of statins and other severe complication; Child-bearing women ; Patients who are or may be pregnant; Other conditions under which patients not pertinent to attend the study as judged by the investigators.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day). | Drug: Rosuvastatin<br>* Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.<br>* Other names: RSV;Other: Control<br>* Randomized Treatment Period (Day 1 through Day 14): No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.<br>|
| No Intervention: Control<br>Control group(don't take rosuvastatin until 14th day), as directed by the study physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke |  | 0-14d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke |  | 0-14d | 
| Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke |  | 0-14d | 
| The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group |  | 14-90d | 
| The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group |  | 14-90d | 
| The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group |  | 0-14d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke