Pitavastatin on Carotid Intima-media Thickness

Not Applicable

• Conditions: Hyperlipidemia; Carotid Artery Diseases
• Interventions: Drug: Pitavastatin

• Registration Number: NCT00711919
• Lead Sponsor: Kyoto Prefectural University of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-09
• Last Update Posted: 2009-09-10
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pitavastatin	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.
2	Pitavastatin	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.

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
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
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

Trial Locations

Locations (18)

Ayabe City Hospital; 🇯🇵 Ayabe, Kyoto, Japan

Fukuchiyama City Hospital; 🇯🇵 Fukuchiyama, Kyoto, Japan

Tanabe Central Hospital; 🇯🇵 Kyotanabe, Kyoto, Japan

Kumihama Hospital; 🇯🇵 Kyotango, Kyoto, Japan

Maizuru Medical Center; 🇯🇵 Maizuru, Kyoto, Japan

Maizuru Kyosai Hospital; 🇯🇵 Maizuru, Kyoto, Japan

Saiseikai Kyoto Hospital; 🇯🇵 Nagaokakyo, Kyoto, Japan

Nantan General Hospital; 🇯🇵 Nantan, Kyoto, Japan

Meiji University of Integrative Medicine Hospital; 🇯🇵 Nantan, Kyoto, Japan

Gakken Toshi Hospital; 🇯🇵 Seika, Kyoto, Japan

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