Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Aortic adverse events
研究概览
简要总结
Acute Aortic Syndrome (AAS)/Aortic Aneurysm is a common feature of aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, the authors hypothesized that people with acute aortic syndrome but without hyperlipidemia might benefit from statin treatment.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients with aortic dissection/ulceration/intermural hematoma/aortic aneurysm who underwent aortic arch replacement or endoluminal isolation or hybrid therapy;
- •(2) Paitents without clinically significant hyperlipidemia but with cardiovascular disease risk factors (such as male ≥45 years old, female ≥55 years old, hypertension, diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol consumption, family history of early onset ischemic cardiovascular disease) and no previous use of statins;
- •(3) Patients are between 18 and 85 years old, male or female;
- •(4) Agree to participate in the study and sign the informed consent.
排除标准
- •(1) Patients with allergy to statins;
- •(2) patients with active liver disease;
- •(3) patients with myopathy;
- •(4) Lactating women and pregnant women;
- •(5) Patients with mental diseases, drug and alcohol dependence;
- •(6) Refuse to participate in the study or sign the informed consent.
研究组 & 干预措施
Statin
干预措施: Rosuvastatin 10mg (Drug)
结局指标
主要结局
Aortic adverse events
时间窗: 3 months after surgery
a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.
次要结局
- Mortality(3 months after surgery)
研究者
Hong Liu
Principal Investigator of Cardiovascular surgery Dept.
Nanjing Medical University