NCT04270344Unknown不适用
A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 905 人开始时间: 2018年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 905
- 试验地点
- 1
- 主要终点
- all-cause mortality, non-fatal MI, repeat re-vascularization
研究概览
简要总结
Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea
详细描述
Following subjects with AMI event within 1 month will be assessed MACE event for 1year
- Essential hypertension or heart failure
- Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
- Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
- •diagnosed AMI (STEMI, NSTEMI) 1 months ago
- •more than 19 years old and more than 2 years of life expectancy at screening
- •informed consent
排除标准
- •cardiogenic shock or corresponding clinical events
- •contraindicated to the IP
- •unsuitable to this study judged by investigators
结局指标
主要结局
all-cause mortality, non-fatal MI, repeat re-vascularization
时间窗: 12 months
MACE
次要结局
- The change of HbA1c, FBS(6 and 12 months)
- The rate of cardiac death(6 and 12 months)
- The rate of Coronary artery bypass graft(CABG)(6 and 12 months)
- The rate of mortality(6 and 12 months)
- The rate of hospitalization due to heart failure(6 and 12 months)
- The rate of target vessel re-vascularization(6 and 12 months)
- The rate of cerebrovascular disease(6 and 12 months)
- The rate of target lesion re-vascularization(6 and 12 months)
- The change of SBP, DBP(6 and 12 months)
- The rate of nonfatal MI(6 and 12 months)
- The change of TC, TG, HDL-C, LDL-C, hsCRP(6 and 12 months)
研究者
研究点 (1)
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