Pitavastatin on Carotid Intima-media Thickness
PEACE
Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
2 other identifiers
interventional
300
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedSeptember 10, 2009
September 1, 2009
2.4 years
July 7, 2008
September 9, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
absolute changes in carotid intima-media thickness from baseline to final visit
12 months
Secondary Outcomes (6)
relative change in carotid intima-media thickness
12 months
change in LDL-C, HDL-C, TG and RLP-C
12 months
change in hs-CRP and IL-6
12 months
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
12 months
sudden death
12 months
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORSubjects 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
ACTIVE COMPARATORSubjects 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.
Interventions
comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Ayabe City Hospital
Ayabe, Kyoto, 623-0011, Japan
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, 620-8505, Japan
Saiseikai Kyoto Hospital
Kōtari, Kyoto, 617-0814, Japan
Takeda Hospital
Kyoto, Kyoto, 600-8558, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Kyoto First Red Cross Hospital
Kyoto, Kyoto, 605-0981, Japan
Tanabe Central Hospital
Kyōtanabe, Kyoto, 610-0334, Japan
Kumihama Hospital
Kyōtango, Kyoto, 629-3400, Japan
Maizuru Medical Center
Maizuru, Kyoto, 625-8502, Japan
Maizuru Kyosai Hospital
Maizuru, Kyoto, 625-8585, Japan
Nantan General Hospital
Nantan, Kyoto, 629-0197, Japan
Meiji University of Integrative Medicine Hospital
Nantan, Kyoto, 629-0392, Japan
Gakken Toshi Hospital
Sugai, Kyoto, 619-0238, Japan
Uji Hospital
Uji, Kyoto, 611-0011, Japan
Kyoto Prefectural Yosanoumi Hospital
Yotsutsuji, Kyoto, 629-2261, Japan
Shiga Hospital
Higashioumi, Shiga, 527-8505, Japan
Omihachiman Community Medical Center
Ōmihachiman, Shiga, 523-0082, Japan
Saiseikai Shigaken Hospital
Rittou, Shiga, 520-3046, Japan
Related Publications (2)
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PMID: 37565307DERIVEDIkeda 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.
PMID: 22689416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hiroaki Matsubara, MD, PhD
Kyoto Prefectural University of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 9, 2008
Study Start
July 1, 2007
Primary Completion
December 1, 2009
Last Updated
September 10, 2009
Record last verified: 2009-09