The Safety and Efficacy Study of High Dose Atorvastatin After Thrombolytic Treatment in Acute Ischemic Stroke "SEATIS"


Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

1. Men or women ≧18 years of age
2. Able and willing to comply with study requirements
3. Signed informed consent by patient self or legally authorized representatives.
4. Baseline mRS before this stroke onset less than 2
5. Receive IV rt-PA thrombolysis with a final diagnosis of ischemic stroke
6. Liver transaminases (ALT and/or AST) ≤ 2 x upper limit of normal (ULN) with no active liver disease and creatine kinase (CK) ≤ 2 x ULN at screen visit.

Exclusion Criteria

1. History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy
2. Patients who have been treated with any other investigational drug within 3 months of enrollment
3. Impaired renal function ( serum creatinine ≧1.5 mg/dL) or nephrotic syndrome
4. Patients hypersensitive or have allergic response to HMG-CoA reductase inhibitors
5. Metastatic neoplasm at the onset or the follow-up
6. Prohibited concomitant therapies, e.g.:
① Medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil and human immunodeficiency virus (HIV) protease inhibitors.
②Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease
7. Patient has evidence of severe congestive heart failure or has history of end-stage cardiovascular disease (e.g. CHF NYHA Class III or IV)
8. Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or confound the results of the study