NCT02069717撤回不适用
Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The incidence rate of the major adverse cardiovascular events (MACE)
研究概览
简要总结
The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients >20 years of age.
- •history of acute myocardial infarction
- •metabolic syndrome diagnosis
排除标准
- •current liver disease or AST or ALT greater than 3 times the upper limit of reference range
- •pre-existing gallbladder disease
- •moderate to severe renal disorder (serum creatinine >2.5mg/dL)
- •pancreatitis diagnosis
结局指标
主要结局
The incidence rate of the major adverse cardiovascular events (MACE)
时间窗: 24 months
cardiac death, MI, re-PCI, CABG
次要结局
- The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)(24 months)
研究者
研究点 (1)
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