Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 主要终点
- ∆Infarct size/Left Ventricular mass%
研究概览
简要总结
Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.
详细描述
The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years;
- •Signed informed consent and expected compliance with protocol;
- •Acute anterior ST segment elevation myocardial infarction;
- •Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
- •Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.
排除标准
- •Cardiogenic shock;
- •Cardiac arrest/ventricular fibrillation;
- •History of severe renal failure, glomerular filtration rate (eGFR) < 30ml/min;
- •History of severe infection, hepatobiliary obstruction or malignant tumor;
- •Receiving immunosuppressive therapy;
- •Women who are pregnant or may become pregnant;
- •There are contraindications to study drugs or magnetic resonance examination;
- •No written informed consent was obtained.
研究组 & 干预措施
Interventional drug treatment group
The participants receive Nivolumab treatment. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour.
干预措施: Nivolumab (Drug)
Placebo treatment group
The participants receive placebo treatment. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour.
干预措施: Placebo (Other)
结局指标
主要结局
∆Infarct size/Left Ventricular mass%
时间窗: 3 months
Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.
The incidence of adverse events
时间窗: up to 3 months
The incidence of adverse events during 3 months after Nivolumab treatment.
次要结局
- ∆Left ventricle end systolic volume/Body surface area(3 months)
- ∆Left ventricle ejection fraction%(3 months)
- ∆Left ventricle end diastolic volume/Body surface area(3 months)
- ∆Troponin T(3 months)
- ∆proBNP(3 months)