NL-OMON36151已完成不适用
Silencing Inflammatory activity by injecting Nanocort in patients at risk for atherosclerotic disease - SILENCE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
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
- 18 至 99（—）
入选标准
- •Target population will consist of subjects with an increased risk for cardiovascular disease and severe inflamed carotid or aortic atherosclerosis plaques.
排除标准
- •1) Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy.
- •2) Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study.
- •3) Recent (< 1 month prior to screening) or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including: oral, rectal, or injectable corticosteroids or immunosuppressive medications (e.g., cyclosporine, methotrexate, tacrolimus, azathioprine, anti-thymocyte globulin, sirolimus, anti-TNF agents such as infliximab, anti-IL6 therapy such as tocilizumab, or anti-IL1 therapy such as anakinra).
- •4) Standard contra-indications to MRI, 18FDG PET, and CT.
- •5) Current medical history of poorly controlled diabetes defined as hemoglobin A1c (HbA1c) >7.5%.
- •6) History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
- •7) Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- •8) Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.
- •9) Current medical history of drug or alcohol abuse within 12 months prior to screening.
- •10) Subjects are not permitted to enter the study if they have taken any investigational drug in the 3 months prior to study drug administration.
- •11) Subjects are not permitted to enter the study if they have taken insulin or any oral anti-diabetic (except metformin) in the last 30 days. Those subjects who are taking metformin may be included in the study if they are on a stable dose for at least 4 weeks and have a HbA1c <7.5%.
- •12) Any contraindications for corticostreoid use (for example but not limited to herpes simplex oculi or vaccinations)
研究者
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