Ischemic
Conditions
Keywords
acute ischemic stroke
Brief summary
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
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.
Interventions
DRUGRosuvastatin
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.
OTHERControl
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 45 to 75 years old patients; 2. Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences; 3. Time from symptom onset to take the study assigned medication is within 24 hours; 4. Statin naïve or discontinued at least 3 month before stroke onset; 5. First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event; 6. Moderate neurological deficit with baseline NIHSS scoring from 4-20; 7. MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset; 8. Consent form signed.
Exclusion criteria
\- Any of the following is regarded as a criterion for exclusion from the study: 1. Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences; 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke | 0-14d |
Secondary
| Measure | 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 |
Outcome results
None listed