Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Locations
- 18
- Primary Endpoint
- absolute changes in carotid intima-media thickness from baseline to final visit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.
Intervention: Pitavastatin (Drug)
2
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.
Intervention: Pitavastatin (Drug)
Outcomes
Primary Outcomes
absolute changes in carotid intima-media thickness from baseline to final visit
Time Frame: 12 months
Secondary Outcomes
- change in hs-CRP and IL-6(12 months)
- change in LDL-C, HDL-C, TG and RLP-C(12 months)
- new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans(12 months)
- relative change in carotid intima-media thickness(12 months)
- sudden death(12 months)
- side effects(12 months)