UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of fatty acid composition in plaque in patients undergoing carotid artery endarterectomy
Title of the study (Brief title)	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	Takakazu Kawamata
Organization	Tokyo Women's Medical University
Division name	Neurosurgery
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	tkawamata@twmu.ac.jp

Public contact
Name of contact person	Tatsuya Ishikawa
Organization	Tokyo Women's Medical University
Division name	Neurosurgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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