Hypercholesterolemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with fasting LDL-C >= 100 mg/dL and < 140 mg/dL. 2) Patients with fasting triglyceride < 400 mg/dL 3) Patients who are able to submit written consent agreement by themselves
Exclusion criteria
Exclusion criteria: (1) Patients with familial hypercholesterolemia (2) Patients who took lipid lowering agent within 1 month before the study . (3) Patients who have undergone PCI/CABG in separate sites of coronary arteries. (4) Patients with history of unstable angina or ischemic syndrome. (5) Patients with concomitant cardiac failure and patients who have lowered cardiac functions. (6) Patients receiving insulin treatment (7) Patients receiving cyclosporine (8) Patients with hepatic function disorder (AST/ALT>=100 IU/L) (9) Patients with renal function disorder (serum creatinine >= 1.5 mg/dL) (10) Patients with serum CK >= 500 IU/L (11) Pregnant women and women suspected of being pregnant (12) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder (13) Patients with drug abuse or alcoholism (14) Patients with serious complication (15) Patients who are ineligible at physicians' discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in MLD and ALD at month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Virtual histology intravascular ultrasound (VH-IVUS) and 64-row multi-detector-row computed tomography (64-row MDCT) will be conducted in patients who meet enablement requirement, and the relationship between changes in quantity of coronary plaque and quality of plaque will be evaluatedexploratory . Changes of intima media thickness (IMT) in carotid artery will be exploratory evaluated in patients who meet enablement requirement. | — |
Countries
Japan
Contacts
Public Health Research Foundation Lifestyle-related disease clinical study support office