UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies.
Title of the study (Brief title)	Lotriga Residual Risk Reduction Trial LR3 Trial
Region	Japan

Condition
Condition	The subjects with hyper-triglyceridemia and atherosclerosis.
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of current study entitled, Lotriga Residual Risk Reduction Trial, is to elucidate the unknown relationships among hypertriglyceridemia, commensal microbes and auto-antibodies for development and progression of human atherosclerosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Primary Objectives: Changes of serum TG(triglyceride) concentrations, fatty acids four fractions before, during, and after clinical trials as for indexes of pharmaceutical efficacy.
Key secondary outcomes	Secondary Objectives: Changes of fecal commensal microbiota. (T-RFLP), fecal IgA, fecal mucin for feces. Changes of serum auto-antibodies (anti-IL5), total IgG, IgG3. Changes of gene expressions of peripheral mononuclear cells. (RT-PCR) Changes of structural, functional markers for atherosclerosis. (cervical US, API/AVI). Occurrences of major adverse cardiovascular events. (MACE)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For study participants, 2 g once a day as omega-3 fatty acid ethylate, Lotriga, is administered in the morning immediately after meals.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion Criteria The subjects who are following criteria are enrolled for the study; age >20 years old, subjects with hyper-triglyceridemia and fasting triglyceride >150mg/dl, subjects with ischemic heart disease (IHD) under current treatment or with history of IHD or subjects with cervical atherosclerosis (ccIMT>1.1mm) or subjects with PAD defined as ABI<0.9, subjects who agree with informed consent by practitioner at enrollment.
Key exclusion criteria	Exclusion criteria are as follows: 1. Patients in whom Lotriga is contraindicated such as patients with a history of hypersensitivity to any ingredient of Lotriga or other omega-3 unsaturated fat, and patients who are bleeding with following conditions; hemophilia, capillary fragility disease, gastrointestinal ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc. 2. Patients with active infection or malignancies 3. Pregnant women, lactating women, and patients who wish to become pregnant 4. Patients who have not provided consent to participate in the study 5. Subjects with active inflammatory diseases or active malignant tumor. 6. Subjects who are already given other omega-3 unsaturated fat regimen. 7. Subjects who are already given other anti-hypertriglyceride medication such as fibrate derivatives, nicotinic acids derivatives. (Subjects who are already given statins are not excluded from participants.) 8. Subjects who are not in consent with research protocol. Furthermore, patients who meet the following criteria will be excluded: 1. Patients with symptomatic heart failure (NYHA class 2 or higher or EF < 40%) 2. Patients with possible type 1 diabetes mellitus 3. Patients who are scheduled to undergo coronary revascularization (Patients who underwent percutaneous transluminal coronary angioplasty including drug-eluting stent placement may be enrolled.) 4. Patients with serious liver or renal disorder 5. Patients who are determined to be not suitable by the investigator for reasons other than the above.
Target sample size	36

Research contact person
Name of lead principal investigator	Tomoaki Ishigami
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Medical Science and Cardio-Renal Medicine
Address	3-9, Fukuura, Kanazawa-ku, YOKOHAMA
TEL	045-787-2635
Email	tommmish@hotmail.com

Public contact
Name of contact person	Kentaro Arakawa
Organization	Yokohama City University Hospital
Division name	Laboratory Medicine
Address	3-9, Fukuura, Kanazawa-ku, YOKOHAMA
TEL	045-787-2635
Homepage URL
Email	hiroking@gamma.ocn.ne.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-Renal Medicine
Institute
Department

Funding Source
Organization	Yokohama City University Graduate School of Medicine
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	公立大学法人横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 04 Month 19 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036844