UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010279 |
|---|---|
| Receipt number | R000012032 |
| Scientific Title | Clinical study of the effect of EPA on carotid artery plaque stabilization |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2013/03/19 15:55:50 |
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Basic information
Public title
Clinical study of the effect of EPA on carotid artery plaque stabilization
Acronym
EPA on carotid artery plaque stabilization (E-CAPS)
Scientific Title
Clinical study of the effect of EPA on carotid artery plaque stabilization
Scientific Title:Acronym
EPA on carotid artery plaque stabilization (E-CAPS)
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to determine the effect of EPA on carotid artery plaque stabilization by MR plaque imaging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of signal intensity ratio (SIR) on MR plaque imaging by EPA administration for 6 months
Key secondary outcomes
1. Changes of max intima-media thickness by EPA administration for 6 months
2. Ipsilateral carotid ischemic events during the study period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eicosapentaenoic acid (EPA)
Interventions/Control_2
no treatment
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
1. The patients (aged 20-80 yeard old) with mild to moderate carotid artery stenosis, which is not indicated for surgical revascularization.
2. The patients taking strong statin for more than 30 days.
3. When written consent is obtained from the legal guardians of each patient
Key exclusion criteria
1. The patients are taking EPA
2. The patients who have a history of hepersensitivity to EPA
3. The patients to whom EPA's contraindication (patients who are hemorrhaging).
4. The patients whose physician in charge judged that participation in this study is not appropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Homepage URL
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Preinitiation
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 19 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012032
