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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | 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). |
|
| Control | No Intervention | Control group(don't take rosuvastatin until 14th day), as directed by the study physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
Any of the following is regarded as a criterion for exclusion from the study:
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| Control | Other | 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. |
|
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |