Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-related Adverse Events
研究概览
简要总结
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA
排除标准
- •Taking a CYP3A4 metabolized drug (such as cyclosporine)
研究组 & 干预措施
Atorvastatin and anakinra
Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day
干预措施: Atorvastatin and anakinra (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events
时间窗: 6 weeks
The number of participants with adverse events related to study drugs will be assessed and reported
次要结局
未报告次要终点
研究者
Adriana H. Tremoulet
Professor
University of California, San Diego
