Pitavastatin on Carotid Intima-media Thickness

NCT ID: NCT00711919

Last Updated: 2009-09-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia Carotid Artery Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Pitavastatin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Pitavastatin

Intervention Type DRUG

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.

Intervention Type DRUG

Pitavastatin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto Prefectural University of Medicine

OTHER

Sponsor Role lead

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

Site Status

Fukuchiyama City Hospital

Fukuchiyama, Kyoto, Japan

Site Status

Saiseikai Kyoto Hospital

Kōtari, Kyoto, Japan

Site Status

Takeda Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Kyoto First Red Cross Hospital

Kyoto, Kyoto, Japan

Site Status

Tanabe Central Hospital

Kyōtanabe, Kyoto, Japan

Site Status

Kumihama Hospital

Kyōtango, Kyoto, Japan

Site Status

Maizuru Medical Center

Maizuru, Kyoto, Japan

Site Status

Maizuru Kyosai Hospital

Maizuru, Kyoto, Japan

Site Status

Nantan General Hospital

Nantan, Kyoto, Japan

Site Status

Meiji University of Integrative Medicine Hospital

Nantan, Kyoto, Japan

Site Status

Gakken Toshi Hospital

Sugai, Kyoto, Japan

Site Status

Uji Hospital

Uji, Kyoto, Japan

Site Status

Kyoto Prefectural Yosanoumi Hospital

Yotsutsuji, Kyoto, Japan

Site Status

Shiga Hospital

Higashioumi, Shiga, Japan

Site Status

Omihachiman Community Medical Center

Ōmihachiman, Shiga, Japan

Site Status

Saiseikai Shigaken Hospital

Rittou, Shiga, Japan

Site Status

Countries

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Japan

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.

Reference Type DERIVED
PMID: 37565307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22689416 (View on PubMed)

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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