UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001229 |
|---|---|
| Receipt number | 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 17:22:46 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001497
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
