UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004114 |
|---|---|
| Receipt number | R000004948 |
| Scientific Title | Evaluation of the effect of eicosapentaenoic acid on plaques in human carotid arteries |
| Date of disclosure of the study information | 2010/08/27 |
| Last modified on | 2016/02/29 21:09:16 |
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Basic information
Public title
Evaluation of the effect of eicosapentaenoic acid on plaques in human carotid arteries
Acronym
EPA on CEA study
Scientific Title
Evaluation of the effect of eicosapentaenoic acid on plaques in human carotid arteries
Scientific Title:Acronym
EPA on CEA study
Region
| Japan |
Condition
Condition
Atherosclerotic plaques in carotid arteries.
Classification by specialty
| Medicine in general | Vascular surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of EPA on the stabilization of plaques in human carotic arteries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stabilization of plaques in human carotid arteries.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Administration of eicosapentate acid (1800mg/day) for 30 days.
Interventions/Control_2
Administration of placebo for 30 days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo carotid endarterectomy in Tokushima University Hospital.
Key exclusion criteria
1. Patients who have allergy for EPA.
2. Patients who have bleeding tendency.
3. Patients who had acute cerebral attack within six months.
4. Patients who has a history of peptic ulcer.
5. Patients whom doctors decided to exclude from this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Sata |
Organization
Institute of Health Biosciences, the University of Tokushima Graduate School
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima city, Tokushima 770-8503, Japan
TEL
+81-88-633-7851
masataka.sata@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Yamada |
Organization
Institute of Health Biosciences, the University of Tokushima Graduate School
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima city, Tokushima 770-8503, Japan
TEL
+81-88-633-7851
Homepage URL
yamada.md@gmail.com
Sponsor or person
Institute
Institute of Health Biosciences, the University of Tokushima Graduate School, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Knowledge Cluster and New Research Area
Organization
Division
Category of Funding Organization
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 27 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004948
| 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 |
