Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with acute Ischemic Stroke (ARIS study)
- Conditions
- Hypercholesterolemia coupled with ischemic stroke
- Registration Number
- JPRN-UMIN000004608
- Lead Sponsor
- Department of Stroke Treatment,Shonan Kamakura General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
1) Patients with Japan Coma Scale (JCS) greater than 10 (Patients who cannot take foods orally) 2) Patients who have received atorvastatin or rosuvastatin before the observation period 3) Patients with familial hypercholesterolemia or secondary hyperlipidemia 4) Patients with the fasting TG level of more than 400 mg/dL 5) Patients with hypersensitivity to HMG-CoA reductase inhibitor(statin) 6) Patients within 3 months of stroke onset 7) Patients with active liver disease (ALT or AST levels more than 100IU/L, or a total bilirubin of more than 2.5 mg/dL) 8) Patients with renal dysfunction (the serum creatinine more than 2.0 mg/dL or Ccr<30mL/min/1.73 square meter) 9) Patients with the serum creatine kinase (CK) levels greater than 500IU/L 10) Patients on treatment with cyclosporine 11) Pregnant and potential pregnancy 12) Patients with hypothyroidism, hereditary myopathy (muscular dystrophy) or family history of hereditary myopathy, and drug-induced myopathy 13) Patients with drug abuse or alcoholism 14) Patients who are ineligible for any other reason in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percent change of LDL-C, HDL-C, TG and high-sensitivity CRP composition after 12 months
- Secondary Outcome Measures
Name Time Method 1) Percent change of LDL-C/HDL-C ratio 2) Percent change of non HDL-C 3) Major adverse cardiac and cerebrovascular events 4) Changes in intima-media thickness (max and mean IMT) 5) Safety