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临床试验/JPRN-UMIN000032320
JPRN-UMIN000032320尚未招募2 期

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 个研究点目标入组 36 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
36

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 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.

研究者

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

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