Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Acute Phase Response (CRP Levels)
研究概览
简要总结
VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days.
详细描述
VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anakinra (standard dose)
Anakinra 100 mg daily for 14 days
干预措施: Anakinra 100 mg (Drug)
Anakinra (standard dose)
Anakinra 100 mg daily for 14 days
干预措施: Placebo (Drug)
Anakinra (high dose)
Anakinra 100 mg twice daily for 14 days
干预措施: Anakinra 100 mg (Drug)
Placebo
Placebo for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Phase Response (CRP Levels)
时间窗: 14 days
Comparison of area-under-the-curve for CRP up to day 14
次要结局
- Left Ventricular Ejection Fraction(12 months)
- Left Ventricular End-systolic Volume(12 months)
- Heart Failure(12 months)