Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies. - Lotriga Residual Risk Reduction Trial LR3 Trial

Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-Renal Medicine0 sites36 target enrollmentApril 20, 2018

ConditionsThe subjects with hyper-triglyceridemia and atherosclerosis.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: The subjects with hyper-triglyceridemia and atherosclerosis.
Sponsor: Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-Renal Medicine
Enrollment: 36
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 20, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

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

Eligibility Criteria

Inclusion Criteria

Not provided

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.