hypercholesterolemia
Conditions
Interventions
Pitavastatin 2mg will be administered after a meal in the evening. Duration of treatment: 5 years
Atorvastatin 10mg will be administered after a meal in the evening. Duration of treatment: 5 years
Sponsors
Toho University Sakura Medical Center Center of Diabestes, Endocrinology & Metabolism
Toho University Oomori Medical Center Toho University Ohashi Medical Center Toho University Faculty of Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hypercholesterolemia(TC>=220mg/dL, LDL-C>=140mg/dL) 2. Patient who has one or more of arteriosclerosis disease risk factors a. Type 2 diabetes(HbA1c>=6.0%, GA>=18.0%) b. Ischemic heart disease patients who have 50% or more stenosis in a coronary artery c. Acute MI or unstable angina d. PCI or CABG e. Cerebral infarction f. Arteriosclerosis obliterans 4. Age 35 or more 5. Men and women 6. Written consent for participation in the study by their own volition after being provided sufficient explanation for participation into this clinical trial
Exclusion criteria
Exclusion criteria: 1. Heart failure NYHA III or greater 2. Severe nephropathy 3. Scheduled for PCI, CABG and leg procedure for peripheral vascular disease 4. Malignancy or high risk for malignancy 5. Uncontrolled diabetes 6. Receiving probucol 7. Familial hypercholesterolemia 8. Contraindication or relative contraindication to statin Rx 9. Individuals who are ineligible in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end-point (composite end-point): 1. Cardiac disease a. Non-fatal myocardial infraction b. Angina c. Congestive heart failure 2. Recent coronary revascularization 3. Non-fatal cerebrovascular event a. Cerebral apoplexy b. Cerebral infarction c. Subarachnoid hemorrhage d. Transient ischemic attack 4. Peripheral artery disease a. Arteriosclerosis obliterans b. Aortic aneurysm 5. Lower limb amputation 6. Lower limb bypass surgery or revascularization procedure 7. Fatal acute myocardial infarction or fatal cerebrovascular event 8. Sudden death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to development of composite primary endpoint 2. Incidence of individual primary endpoints 3. Time to development of incidence of individual primary endpoints 4. Incidence of diabetic nephropathy 5. Incidence of atrial fibrillation 6. Non-HDL-C; LDL-C; HDL-C; Triglyceride; Serum creatinine; Fasting plasma glucose; HbA1c or glycosylated albumin; 0.5% increase of HbA1c; Preheparin LPL mass; Urinary albumin; Urinary 8-hydroxydeoxyguanosine(OhdG); 8-iso-prostaglandin F2 alpha(PGF2alpha); Small dense LDL 7. Non-HDL-C goal of the NCEP Adult Treatment Panel III 8. LDL-C goal of Japan Atherosclerosis Society(JAS) Guidelines 2002 | — |
Countries
Japan
Contacts
Public ContactYoh Miyashita
Toho University Sakura Medical Center Center of Diabestes, Endocrinology & Metabolism
Outcome results
None listed