TOHO lipid intervention trial using pitavastatin(TOHO-LIP)

UMIN ID: UMIN000001404

Registered date:30/09/2008

Basic Information

• Health condition(s) or Problem(s) studied: hypercholesterolemia
• Date of first enrollment: 2006/04/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Toho University Sakura Medical Center Center of Diabestes, Endocrinology & Metabolism
• Secondary Sponsor: Toho University Oomori Medical Center Toho University Ohashi Medical Center Toho University Faculty of Pharmaceutical Sciences
• Source(s) of Monetary Support: None