NL-OMON39440已完成2 期
Evaluation of the subcutaneous administration of 30 mg of S78989 versus placebo and evaluation of the subcutaneous administration of 60mg of S78989 versus placebo, on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. A 28-weeks, randomized, double-blind, parallel-group, placebo controlled, international multicenter exploratory pilot study. - S78989-009
I.R.I.S0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
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
- •Main selection criteria:
- •* Male or female of non-childbearing potential (contraception allowed), aged over 50 years with a documented recent (3-12 months) acute coronary syndrome (ACS) defined as the association of a chest pain episode or its equivalent and either:
- •o elevated troponin
- •o Percutaneous Coronary Intervention (PCI) performed because of the related ACS event
- •o significant coronary stenosis (visual assessment before any percutaneous dilatation) diagnosed in at least one native vessel on a coronary angiography performed after the event.
- •* Informed consent signed
- •* All revascularization procedures planned after the acute event, completed at least 3 months before selection visit
- •* Use of statins since at least 3 months before selection, and no change in use of any antidyslipidemic treatment within the 2 months prior to selection en between selection and inclusion.
- •Main inclusion criteria
- •* Patients with a maximum mean Target to Background Ratio (TBR), measured by 18-FDG PET/CT in any region of interest (left carotid, right carotid, thoracic aorta) > 1.8 at selection visit.
排除标准
- •Main-non selection/non-inclusion
- •*Pregnancy
- •*Type I diabetes or uncontrolled diabetes (HBA1c>9.5%),
- •*History of heart surgery (including coronary artery bypass graft surgery) within 1 year prior to selection,
- •*Chronic inflammatory diseases,
- •*History or symptoms of demyelinating disease
- •*History of malignancy within 3 years other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin,
- •*Recent or active infectious diseases,
- •*Chronic infectious diseases including active tuberculosis, HIV and hepatitis B or C,
- •*Known immunodeficiency,
- •-Corticosteroids (>20mg/day of prednisolone or equivalent within 1 month previous selection)
- •-Biologic or immunosuppressive therapy within 3 months previous selection
- •-Live vaccine within 3 months prior to selection (with the exception of live seasonal flu and live HN1 vaccins that are permitted until 2 weeks before inclusion).
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