Pitavastatin on Carotid Intima-media Thickness

Hyperlipidemia Clinical Trial

— PEACE  

Official title:

Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00711919
• Other study ID #: C-255
• Secondary ID: UMIN000001229
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2008
• Last updated: September 9, 2009
• Start date: July 2007

Study information

• Verified date: September 2009
• Source: Kyoto Prefectural University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Pitavastatin
comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
• Pitavastatin
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Locations

Country	Name	City	State
Japan	Ayabe City Hospital	Ayabe	Kyoto
Japan	Fukuchiyama City Hospital	Fukuchiyama	Kyoto
Japan	Shiga Hospital	Higashioumi	Shiga
Japan	Tanabe Central Hospital	Kyotanabe	Kyoto
Japan	Kumihama Hospital	Kyotango	Kyoto
Japan	Kyoto First Red Cross Hospital	Kyoto
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Takeda Hospital	Kyoto
Japan	Maizuru Kyosai Hospital	Maizuru	Kyoto
Japan	Maizuru Medical Center	Maizuru	Kyoto
Japan	Saiseikai Kyoto Hospital	Nagaokakyo	Kyoto
Japan	Meiji University of Integrative Medicine Hospital	Nantan	Kyoto
Japan	Nantan General Hospital	Nantan	Kyoto
Japan	Omihachiman Community Medical Center	Omihachiman	Shiga
Japan	Saiseikai Shigaken Hospital	Rittou	Shiga
Japan	Gakken Toshi Hospital	Seika	Kyoto
Japan	Uji Hospital	Uji	Kyoto
Japan	Kyoto Prefectural Yosanoumi Hospital	Yosano	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute changes in carotid intima-media thickness from baseline to final visit		12 months	No
Secondary	relative change in carotid intima-media thickness		12 months	No
Secondary	change in LDL-C, HDL-C, TG and RLP-C		12 months	No
Secondary	change in hs-CRP and IL-6		12 months	No
Secondary	new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans		12 months	No
Secondary	sudden death		12 months	No
Secondary	side effects		12 months	Yes