Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy (PEACE)

UMIN ID: UMIN000001229

Registered date:01/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hyperlipidemia carotid artery atherosclerosis
• Date of first enrollment: 2007/07/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
• Source(s) of Monetary Support: Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
• Secondary ID(s): NCT00711919