Hypercholesterolemia coupled with ischemic stroke
Conditions
Interventions
Rosuvastatin will be administered within 7 days after ischemic stroke onset and continued for 12 months at a dosage of 5mg/day. If treatment fails to reduce the LDL-C level enough, the dosage can be i
Sponsors
Department of Stroke Treatment,Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients within 7 days of stroke onset 2) Patients with the LDL-C level of more than 120 mg/dL 3) Patients aged 20 years or older at the time of giving consent 4) No limitations on gender or hospitalization status 5) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change of LDL-C, HDL-C, TG and high-sensitivity CRP composition after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYuichi Miyazaki
Shonan Kamakura General Hospital Department of Stroke Treatment
Outcome results
None listed