Pitavastatin on Carotid Intima-media Thickness

N/AUnknownNCT00711919

Kyoto Prefectural University of Medicine300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Hyperlipidemia Carotid Artery Diseases

Interventions

PitavastatinDRUG

comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.

PitavastatinDRUG

Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (18)

Ayabe City Hospital

Ayabe, Kyoto, Japan

Fukuchiyama City Hospital

Fukuchiyama, Kyoto, Japan

Outcomes

Primary Outcomes

absolute changes in carotid intima-media thickness from baseline to final visit

Time frame: 12 months

Secondary Outcomes

relative change in carotid intima-media thickness

Time frame: 12 months

change in LDL-C, HDL-C, TG and RLP-C

Time frame: 12 months

change in hs-CRP and IL-6

Time frame: 12 months

new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans

Time frame: 12 months

sudden death

Time frame: 12 months

side effects

Time frame: 12 months

Data from ClinicalTrials.gov

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