Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events
研究概览
简要总结
This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female ≥ 18 years of age
- •Patients with myocardial ischemic syndromes (with any of the following):
- •Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
- •Participate voluntarily and sign an informed consent
排除标准
- •i. Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses
研究组 & 干预措施
PCSK9 inhibitor
the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later
干预措施: PCSK9 inhibitor (Drug)
Statin
the control group will receive standard statin therapy.
干预措施: Statin (Drug)
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events
时间窗: 6 months after surgery
Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke
次要结局
- C-reactive protein(6 months after surgery)
研究者
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University