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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001229
Receipt No. R000001497
Scientific Title Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy (PEACE)
Date of disclosure of the study information 2008/08/01
Last modified on 2012/07/02

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Basic information
Public title Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy (PEACE)
Acronym Pitavastatin on carotid intima-media thickness
Scientific Title Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy (PEACE)
Scientific Title:Acronym Pitavastatin on carotid intima-media thickness
Region
Japan

Condition
Condition hyperlipidemia
carotid artery atherosclerosis
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pitavastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_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.
Interventions/Control_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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Subjects who are diagnosed as having hyperlipidemia, and LDL-C at the time of enrollment is no less than 100
Subjects whose common carotid IMT is 1.1 mm and over
Key exclusion criteria Subjects who received or are planned to receive intervention on carotid arteries during the study period
Subjects with overt liver dysfunction (ALT; 100 IU/L and over)
Subjects with overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
Subjects receiving Cyclosporin
Subjects hyperreactive to Pitavastatin
Subjects with pregnancy or lactation

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsubara
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto Prefectural University of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5511
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine,
Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine,
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00711919
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22689416
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 02 Day
Last modified on
2012 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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