UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034171 |
|---|---|
| Receipt number | R000038952 |
| Scientific Title | Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy |
| Date of disclosure of the study information | 2018/09/17 |
| Last modified on | 2018/09/16 20:18:48 |
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Basic information
Public title
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Acronym
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Scientific Title
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Scientific Title:Acronym
Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will administer EPA, which has an effect of inhibiting the progression of arteriosclerosis, to CEA patients, measure the EPA concentration in vascular tissues not reported in Japan, and compare with the usual treatment method to investigate the progress of arteriosclerosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1)Tissue fatty acid fraction
EPA / AA ratio, DHA / AA ratio
2)Tissue inflammatory cell evaluation
CD68
3)echo examination
Carotid echo
Key secondary outcomes
1)Blood data including blood lipids
TG, LDL-Chol, HDL-Chol, T-Chol, non-HDL-Chol, AST, ALT, ALP, total bilirubin, total protein, albumin, BUN, Cre, eGFR, Na, K, Cl
2)Blood fatty acid fraction
EPA / AA ratio, DHA / AA ratio
3)blood inflammation marker
hs-CRP
PTX 3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous treatment continued for a certain period of time Administration group to which EPA is not administered (40 cases).
Interventions/Control_2
EPA group (40 patients) who newly added 1800 mg / day of a high-purity EPA preparation (Epadel S) to the treatment that was being conducted until then.
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
1. Carotid artery plaque has been confirmed, patients undergoing cerebral neurosurgery CEA
2. Patients who are taking statins diagnosed as dyslipidemia
3. Patients taking antiplatelet drugs
4. Patients aged between 20 and 85
Key exclusion criteria
1. Patients with a history of hypersensitivity to high-purity EPA preparations
2. Omega-3 fatty acid preparation (Rotriga)/Patient taking EPA preparation
3. Bleeding patients (hemophilia, capillary vulnerability, gastrointestinal bleeding, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage etc.)
4. People with peptic ulcer
5. Other patients who are considered inappropriate by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takakazu Kawamata |
Organization
Tokyo Women's Medical University
Division name
Neurosurgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
tkawamata@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ishikawa |
Organization
Tokyo Women's Medical University
Division name
Neurosurgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
tishikawa@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 17 | 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
| 2016 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 27 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038952
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| Registered date | File name |
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