Carotid Artery Diseases, Hyperlipidemia
Conditions
Brief summary
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
Interventions
DRUGPitavastatin
comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
Sponsors
Kyoto Prefectural University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed as having hyperlipidemia * LDL-C at the time of enrollment is no less than 100 * Common carotid IMT is 1.1 mm and over
Exclusion criteria
* Received or planned to receive intervention on carotid arteries during the study period * Overt liver dysfunction (ALT; 100 IU/L and over) * Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over) * Receiving Cyclosporin * Hyperreactive to Pitavastatin * During pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| absolute changes in carotid intima-media thickness from baseline to final visit | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| change in LDL-C, HDL-C, TG and RLP-C | 12 months |
| change in hs-CRP and IL-6 | 12 months |
| relative change in carotid intima-media thickness | 12 months |
| sudden death | 12 months |
| side effects | 12 months |
| new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans | 12 months |
Countries
Japan
Outcome results
None listed