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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034171
Receipt No. 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

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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
Email 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
Email tishikawa@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038952

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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