UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032320
Receipt number R000036844
Scientific Title Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies.
Date of disclosure of the study information 2018/04/20
Last modified on 2018/04/19 18:11:26

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Basic information

Public title

Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies.

Acronym

Lotriga Residual Risk Reduction Trial
LR3 Trial

Scientific Title

Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies.

Scientific Title:Acronym

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

1st name
Middle name
Last name Tomoaki Ishigami

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science and Cardio-Renal Medicine

Zip code


Address

3-9, Fukuura, Kanazawa-ku, YOKOHAMA

TEL

045-787-2635

Email

tommmish@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Arakawa

Organization

Yokohama City University Hospital

Division name

Laboratory Medicine

Zip code


Address

3-9, Fukuura, Kanazawa-ku, YOKOHAMA

TEL

045-787-2635

Homepage URL


Email

hiroking@gamma.ocn.ne.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



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

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


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

Preinitiation

Date of protocol fixation

2018 Year 03 Month 05 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036844


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name