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Pitavastatin on Carotid Intima-media Thickness (PEACE)

Primary Purpose

Hyperlipidemia, Carotid Artery Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pitavastatin
Pitavastatin
Sponsored by
Kyoto Prefectural University of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ayabe City Hospital
  • Fukuchiyama City Hospital
  • Tanabe Central Hospital
  • Kumihama Hospital
  • Maizuru Medical Center
  • Maizuru Kyosai Hospital
  • Saiseikai Kyoto Hospital
  • Nantan General Hospital
  • Meiji University of Integrative Medicine Hospital
  • Gakken Toshi Hospital
  • Uji Hospital
  • Kyoto Prefectural Yosanoumi Hospital
  • Shiga Hospital
  • Omihachiman Community Medical Center
  • Saiseikai Shigaken Hospital
  • Takeda Hospital
  • Kyoto Prefectural University of Medicine
  • Kyoto First Red Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2008
Last Updated
September 9, 2009
Sponsor
Kyoto Prefectural University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00711919
Brief Title
Pitavastatin on Carotid Intima-media Thickness
Acronym
PEACE
Official Title
Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kyoto Prefectural University of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Carotid Artery Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm 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.
Arm Title
2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.
Primary Outcome Measure Information:
Title
absolute changes in carotid intima-media thickness from baseline to final visit
Time Frame
12 months
Secondary Outcome Measure Information:
Title
relative change in carotid intima-media thickness
Time Frame
12 months
Title
change in LDL-C, HDL-C, TG and RLP-C
Time Frame
12 months
Title
change in hs-CRP and IL-6
Time Frame
12 months
Title
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
Time Frame
12 months
Title
sudden death
Time Frame
12 months
Title
side effects
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, MD, PhD
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ayabe City Hospital
City
Ayabe
State/Province
Kyoto
ZIP/Postal Code
623-0011
Country
Japan
Facility Name
Fukuchiyama City Hospital
City
Fukuchiyama
State/Province
Kyoto
ZIP/Postal Code
620-8505
Country
Japan
Facility Name
Tanabe Central Hospital
City
Kyotanabe
State/Province
Kyoto
ZIP/Postal Code
610-0334
Country
Japan
Facility Name
Kumihama Hospital
City
Kyotango
State/Province
Kyoto
ZIP/Postal Code
629-3400
Country
Japan
Facility Name
Maizuru Medical Center
City
Maizuru
State/Province
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
Maizuru Kyosai Hospital
City
Maizuru
State/Province
Kyoto
ZIP/Postal Code
625-8585
Country
Japan
Facility Name
Saiseikai Kyoto Hospital
City
Nagaokakyo
State/Province
Kyoto
ZIP/Postal Code
617-0814
Country
Japan
Facility Name
Nantan General Hospital
City
Nantan
State/Province
Kyoto
ZIP/Postal Code
629-0197
Country
Japan
Facility Name
Meiji University of Integrative Medicine Hospital
City
Nantan
State/Province
Kyoto
ZIP/Postal Code
629-0392
Country
Japan
Facility Name
Gakken Toshi Hospital
City
Seika
State/Province
Kyoto
ZIP/Postal Code
619-0238
Country
Japan
Facility Name
Uji Hospital
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0011
Country
Japan
Facility Name
Kyoto Prefectural Yosanoumi Hospital
City
Yosano
State/Province
Kyoto
ZIP/Postal Code
629-2261
Country
Japan
Facility Name
Shiga Hospital
City
Higashioumi
State/Province
Shiga
ZIP/Postal Code
527-8505
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Omihachiman
State/Province
Shiga
ZIP/Postal Code
523-0082
Country
Japan
Facility Name
Saiseikai Shigaken Hospital
City
Rittou
State/Province
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Takeda Hospital
City
Kyoto
ZIP/Postal Code
600-8558
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto First Red Cross Hospital
City
Kyoto
ZIP/Postal Code
605-0981
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22689416
Citation
Ikeda K, Takahashi T, Yamada H, Matsui K, Sawada T, Nakamura T, Matsubara H; (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study). Eur J Prev Cardiol. 2013 Dec;20(6):1069-79. doi: 10.1177/2047487312451539. Epub 2012 Jun 11.
Results Reference
derived

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Pitavastatin on Carotid Intima-media Thickness

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