Pitavastatin on Carotid Intima-media Thickness (PEACE)

Kyoto Prefectural University of Medicine

Status: Unknown

Conditions: Hyperlipidemia; Carotid Artery Diseases

Treatments: Drug: Pitavastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00711919

C-255

UMIN000001229

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Drug: Pitavastatin

Drug: Pitavastatin

2

Active Comparator group

Description:

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.

Treatment:

Drug: Pitavastatin

Drug: Pitavastatin