Cerebral infarction (except for TIA or cardioembolic) with hypercholesterolemia
Conditions
Interventions
Experimental: strong statin treatment Participants received strong statin tablet orally once daily for 90days, which is initiated within 24 hours after admission Atorvastatin 20 mg or Pitavasttain 4
Sponsors
Hyogo college of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who give us the consent of participation with the document by their free will or by substitutes when subjects cannot do it by themselves Inpatients At least 20 years of age Acute ischemic stroke subjects within 24 hours after onset Subjects whose diagnosis are confirmed as cerebral infarction except for TIA by MRI at transport to hospital. Subjects with hypercholesterolemia (serum LDL-C value of 100 mg / dL or more, or diagnosed as hypercholesterolemia before) Subjects who can orally take drugs in within 24 hours after admission Subjects who can be treated according to this study procedures during study period
Exclusion criteria
Exclusion criteria: Subjects with history of hypersensitivity to the agent of this study Subjects with deterioration in liver function attributable to acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis, liver cancer, jaundice, and so on, or with suspected biliary obstruction Subjects who are administered cyclosporine or telaprevir Subjects with moderate or severe renal impairment (SCr>=2.5mg/dL or eGFR<30mg/dL) Subjects who received a diagnosis of acute coronary syndrome within 6 months Subjects with valvular disease, atrial fibrillation, atrial thrombosis Subjects with familial hypercholesterolemia Subjects who are pregnant or may be Subjects whose NIHSS scores are 20 or higher on admission, or mRS score was more than 2 before the onset Subjects that doctors deemed inappropriate by other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of disability or dependence in the daily routine activities [Time Frame: 90 days from admission] [Designated as safety issue: No] Degree of disability or dependence in the daily routine activities: modified Rankin Scale (mRS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative evaluation of stroke-related neurologic deficit [Time Frame: 7 days from admission] [Designated as safety issue: No] The clinical stroke assessment to evaluate neurological status: The National Institutes of Health Stroke Scale (NIHSS) Changes in lipid profile [Time Frame: At admission and earlier day either 21th day from admission or discharge] [Designated as safety issue: No ] LDL-C value is calculated by Friedewald formula. Occurrence of major adverse cardiac and cerebrovascular event [ Time Frame: During admission and 90 days from initial admission ] [ Designated as safety issue: Yes ] Major adverse cardiac and cerebrovascular events include acute myocardial infarction, unstable angina, new-onset cerebral infarction, non-traumatic intracerebral hemorrhage, subarachnoidal hemorrhage and large vessel disease or peripheral artery disease to be treated. Changes in laboratory test values and occurrence of pneumonia[ Time Frame: At admission and earlier day either 21th day from admission or discharge ] [ Designated as safety issue: Yes ] Safety [ Time Frame: During initial admission and 90days from admission ] [ Designated as safety issue: Yes ] | — |
Countries
Japan
Contacts
Public ContactUchida Kazutaka
Hyogo college of medicine Neurosurgery
Outcome results
None listed