Pitavastatin on Carotid Intima-media Thickness (PEACE)

September 9, 2009 updated by: Kyoto Prefectural University of Medicine

Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 602-8566
        • Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 605-0981
        • Kyoto First Red Cross Hospital
      • Kyoto, Japan, 600-8558
        • Takeda Hospital
    • Kyoto
      • Ayabe, Kyoto, Japan, 623-0011
        • Ayabe City Hospital
      • Fukuchiyama, Kyoto, Japan, 620-8505
        • Fukuchiyama City Hospital
      • Kyotanabe, Kyoto, Japan, 610-0334
        • Tanabe Central Hospital
      • Kyotango, Kyoto, Japan, 629-3400
        • Kumihama Hospital
      • Maizuru, Kyoto, Japan, 625-8502
        • Maizuru Medical Center
      • Maizuru, Kyoto, Japan, 625-8585
        • Maizuru Kyosai Hospital
      • Nagaokakyo, Kyoto, Japan, 617-0814
        • Saiseikai Kyoto Hospital
      • Nantan, Kyoto, Japan, 629-0197
        • Nantan General Hospital
      • Nantan, Kyoto, Japan, 629-0392
        • Meiji University of Integrative Medicine Hospital
      • Seika, Kyoto, Japan, 619-0238
        • Gakken Toshi Hospital
      • Uji, Kyoto, Japan, 611-0011
        • Uji Hospital
      • Yosano, Kyoto, Japan, 629-2261
        • Kyoto Prefectural Yosanoumi Hospital
    • Shiga
      • Higashioumi, Shiga, Japan, 527-8505
        • Shiga Hospital
      • Omihachiman, Shiga, Japan, 523-0082
        • Omihachiman Community Medical Center
      • Rittou, Shiga, Japan, 520-3046
        • Saiseikai Shigaken Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Drug: Pitavastatin

comparison of different target levels of lipid lowering using Pitavastatin

Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.

Drug: Pitavastatin
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.
Active Comparator: 2
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.
Drug: Pitavastatin

comparison of different target levels of lipid lowering using Pitavastatin

Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
absolute changes in carotid intima-media thickness from baseline to final visit
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
relative change in carotid intima-media thickness
Time Frame: 12 months
12 months
change in LDL-C, HDL-C, TG and RLP-C
Time Frame: 12 months
12 months
change in hs-CRP and IL-6
Time Frame: 12 months
12 months
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
Time Frame: 12 months
12 months
sudden death
Time Frame: 12 months
12 months
side effects
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto Prefectural University of Medicine

Investigators

  • Study Chair: Hiroaki Matsubara, MD, PhD, Kyoto Prefectural University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 10, 2009

Last Update Submitted That Met QC Criteria

September 9, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-255
  • UMIN000001229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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