UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002151 |
|---|---|
| Receipt number | 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 16:29:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mkawa@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002631
