Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease: a Randomized Comparison Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCE)
研究概览
简要总结
To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013 ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary prevention. Total 4400 patients with coronary artery disease patients requiring statin treatment were categorized fixed high-potent statin group and targeted LDL-C group. The investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2. Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism, 4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic intervention or operation, 6. ESRD with renal replacement therapy).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients clinically diagnosed with coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- •Patients with signed informed consent
排除标准
- •Pregnant women or women with potential childbearing
- •Patients severe adverse events or hypersensitive to statin or patients with multi-drug allergy.
- •Who had received drug that have a drug interaction with statin (strong inhibitor of cytochrome p-450 3A4 or 2C9)
- •Patients with risk factors for myopathy with hereditary muscle disorder, hypothyroidism, alcohol use disorder, severe hepatic dysfunction (3 times normal reference values) or rhabdomyolysis
- •Life expectancy < 3 years
- •Patient with who can not be followed up for more than 1 year
- •Patients who cannot understand or read the consent form
研究组 & 干预措施
Fixed high-potent statin group
According to 2013 ACC/AHA guideline, patients will be received high-intensity statin therapy (atorvastatin 40mg or rosuvastatin 20mg) regardless of their baseline LDL-C levels.
干预措施: fixed high potent statin therapy (Drug)
Targeted LDL-C goal statin group
Patients will be tiltrated statin intensity guided by follow-up LDL-C level
干预措施: targeted LDL-C goal statin (Drug)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCE)
时间窗: 3 years
次要结局
- numer of other adverse clinical events(3 years)