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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002151
Receipt No. R000002631
Scientific Title Effect of Pitavastatin on Carotid Arteries and Aorta Evaluated by Integrated Backscatter Trans-esophageal Ultrasound and PET/CT
Date of disclosure of the study information 2009/07/01
Last modified on 2015/03/25

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Basic information
Public title Effect of Pitavastatin on Carotid Arteries and Aorta Evaluated by Integrated Backscatter Trans-esophageal Ultrasound and PET/CT
Acronym EPICENTRE study
Scientific Title Effect of Pitavastatin on Carotid Arteries and Aorta Evaluated by Integrated Backscatter Trans-esophageal Ultrasound and PET/CT
Scientific Title:Acronym EPICENTRE study
Region
Japan

Condition
Condition dyslipidemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of pitavastatin and pravastatin on atherosclerotic lesions of carotid arteries and aorta by use of PET/CT and integrated backscatter ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Changes of SUV evaluated by PET/CT
(2) Changes of integrated backscatter values
Key secondary outcomes (1) Changes in lipid profile, intima-media thickness and inflammatory markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pitavastatin 2mg/day
Interventions/Control_2 pravastatin 10mg/day
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with dyslipidemia who need to undergo trans-esophageal ultrasound because of atrial fibrillation or valvular disease
Key exclusion criteria familial hypercholesterolemia
severe hepatic disorder or biliary atresia
malignancy
collagen disease
renal disorder (serum creatinine >= 2.0 mg/dl)
uncontrolled diabetes
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Kawasaki
Organization Gifu University Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6523
Email mkawa@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Kawasaki
Organization Gifu University Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6523
Homepage URL
Email mkawa@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization Non profit foundation
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The pravastatin treatment was less effective on plaque inflammation than pitavastatin treatment. This trend was the same in the carotid arteries and the thoracic aorta. Pitavastatin not only improved the atherosis as measured by IMT and cIBS values but also attenuated inflammation of plaques as measured by max SUV at the same site. The present study indicated that pitavastatin has stronger effects on the regression and stabilization of plaques in the thoracic aorta and carotid arteries compared with pravastatin.
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
2009 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 25 Day
Date analysis concluded
2015 Year 03 Month 25 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 01 Day
Last modified on
2015 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002631

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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