An Open-label Study to Evaluate the Efficacy of Neuraminidase Inhibitor Treatment in ST-Elevation Myocardial Infarction (STEMI) Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Myocardial infarct size at 1 week
研究概览
简要总结
Neuraminidase-1 can cause the removal of terminal sialic acid residues from the cell surface or serum sialyloconjugates. The level of Neu5Ac was positively related to the activity of neuraminidase-1. Elevation of Neu5Ac was observed in myocardial ischemia animal model, as well as patients with coronary artery disease. It is interesting to note that Neu5Ac and its regulatory enzyme neuraminidase-1 seem to play a key role in triggering myocardial ischemic injury. Oseltamivir, a structural mimic of sialic acid, was widely used as anti-influenza drug. It suppressed neuraminidase-1 activity in the heart. Targeting neuraminidase-1 may represent a new therapeutic intervention for coronary artery disease. This project seeks to identify whether neuraminidase inhibitor (Oseltamivir) treatment could decrease the myocardial infarct size in STEMI patients and improve clinical outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 75, regardless of gender;
- •STEMI should be diagnosed by two attending physicians or above, including history, clinical symptoms and signs;
- •Participate voluntarily and sign informed consent, and can be followed up for more than one month.
排除标准
- •Allergic to oseltamivir;
- •Creatinine clearance rate less than 60%;
- •Severe liver insufficiency;
- •Female patients who have or plan to become pregnant;
- •Life expectancy less than one year;
- •Patients refused to comply with the requirements of this study;
- •According to the discretion of investigator, the patient was unable to complete the study or comply with the requirements of the study (for administrative or other reasons).
研究组 & 干预措施
no intervention
Standardized STEMI treatment + no intervention
干预措施: Oseltamivir phosphate capsules (Drug)
Tamiflu (Oseltamivir Phosphate Capsules)
Standardized STEMI treatment + oseltamivir phosphate capsule (75mg, 2 times/day, 7days, oral)
干预措施: Oseltamivir phosphate capsules (Drug)
结局指标
主要结局
Myocardial infarct size at 1 week
时间窗: 1 week
Myocardial infarct size at 1 week after acute myocardial infarction (quantified by Gadolinium-enhanced MRI).
次要结局
- Myocardial infarct size(1 week)
- Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow(1 week)
- The proportion of viable myocardium and ratio of myocardial reperfusion(1 week)
- Composite end point at 1 week(1 week)
- Myocardial infarct size at 3 month(3 month)
- Composite end point at 6 month(6 month)