Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Pitavastatin
comparison of different target levels of lipid lowering using Pitavastatin
Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
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.
Pitavastatin
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* LDL-C at the time of enrollment is no less than 100
* Common carotid IMT is 1.1 mm and over
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Kyoto Prefectural University of Medicine
OTHER
Responsible Party
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Kyoto Prefectural University of Medicine
Principal Investigators
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Hiroaki Matsubara, MD, PhD
Role: STUDY_CHAIR
Kyoto Prefectural University of Medicine
Locations
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Ayabe City Hospital
Ayabe, Kyoto, Japan
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, Japan
Saiseikai Kyoto Hospital
Kōtari, Kyoto, Japan
Takeda Hospital
Kyoto, Kyoto, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Kyoto First Red Cross Hospital
Kyoto, Kyoto, Japan
Tanabe Central Hospital
Kyōtanabe, Kyoto, Japan
Kumihama Hospital
Kyōtango, Kyoto, Japan
Maizuru Medical Center
Maizuru, Kyoto, Japan
Maizuru Kyosai Hospital
Maizuru, Kyoto, Japan
Nantan General Hospital
Nantan, Kyoto, Japan
Meiji University of Integrative Medicine Hospital
Nantan, Kyoto, Japan
Gakken Toshi Hospital
Sugai, Kyoto, Japan
Uji Hospital
Uji, Kyoto, Japan
Kyoto Prefectural Yosanoumi Hospital
Yotsutsuji, Kyoto, Japan
Shiga Hospital
Higashioumi, Shiga, Japan
Omihachiman Community Medical Center
Ōmihachiman, Shiga, Japan
Saiseikai Shigaken Hospital
Rittou, Shiga, Japan
Countries
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References
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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.
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.
Other Identifiers
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UMIN000001229
Identifier Type: -
Identifier Source: secondary_id
C-255
Identifier Type: -
Identifier Source: org_study_id
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