A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Roxadustat in Patients With Acute ST Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Infarct Size
研究概览
简要总结
Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies.
This study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
详细描述
This study is an open-label, paralleled, randomized controlled trial. It aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- •Coronary angiography within 12 hours of symptom onset, with TIMI flow grade 0 - 1 of culprit vessel
- •Primary PCI with TIMI flow grade 2 - 3 after successful intervention
- •Capable and willing to provide informed consent and capable of completing study visits
排除标准
- •Previous acute myocardial infarction history
- •Cardiogenic Shock at admission
- •Previously treated by roxadustat
- •Contraindications of roxadustat treatment
- •Contraindication of Cardiac MRI (e.g. eGFR < 30 ml/min, pacemaker, metal prosthesis, etc.)
研究组 & 干预措施
Roxadustat
Early and short-term Roxadustat treatment
干预措施: Roxadustat (Drug)
结局指标
主要结局
Infarct Size
时间窗: 30 days
Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control
次要结局
- MACE(0 - 1 year)
- Cardiac enzymes - peak concentration(0 - 3 days)
- Left Ventricular Function(1 month, 6 months, 1 year)
- Cardiac enzymes - Area under curve(0 - 3 days)
研究者
RUIYAN ZHANG
Director of Cardiology Department, Chief Physician
Ruijin Hospital