Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy (PEACE)
Not Applicable
- Conditions
- hyperlipidemia carotid artery atherosclerosis
- Registration Number
- JPRN-UMIN000001229
- Lead Sponsor
- Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Subjects who received or are planned to receive intervention on carotid arteries during the study period Subjects with overt liver dysfunction (ALT; 100 IU/L and over) Subjects with overt renal dysfunction (serum creatinine; 2.0 mg/dL and over) Subjects receiving Cyclosporin Subjects hyperreactive to Pitavastatin Subjects with pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
- Secondary Outcome Measures
Name Time Method relative change in carotid intima-media thickness change in LDL-C, HDL-C, TG and RLP-C change in hs-CRP and IL-6 new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans sudden death side effects