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临床试验/NCT01936103
NCT01936103Unknown4 期

Effects of Intensive Statin Therapy on Left Ventricular Function for Patients With the First Acute Anterior Myocardial Infarction After Directly to Percutaneous Coronary Intervention.

Shenyang Northern Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
120
试验地点
1
主要终点
left ventricular function

研究概览

简要总结

First acute anterior myocardial infarction in patients with primary PCI preoperative and postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional -dose therapy , patients can improve left ventricular function , reduce major adverse cardiovascular events .

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age
  • the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI
  • informed consent

排除标准

  • Taking , or the need for long-term use of statins is greater than the initial dose
  • treated with PCI again within a mouth
  • active liver disease or liver dysfunction
  • the diagnosis of myopathy
  • severe renal insufficiency ( serum creatinine > 178umol / L )
  • Statin drug allergy or had a serious adverse reaction
  • severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease
  • malignancy or any other end-stage diseases result in a life expectancy of < 6 months
  • be participating in other clinical studies
  • not suitable for inclusion of the other cases
  • not treated with PCI

研究组 & 干预措施

standard group

Active Comparator

patients in this group received standard statin treatment: Atorvastatin statins 20mg / night .

干预措施: standard group (Drug)

intensive group

Experimental

patients in this group received intensive statin treatment: Admission atorvastatin statins the 80mg, after surgery,atorvastatin 40mg / night,and until 30 days after the operation , and thereafter 20mg / night .

干预措施: intensive group (Drug)

结局指标

主要结局

left ventricular function

时间窗: 30 days

ultrasonic observation of E/A

次要结局

  • the left ventricular function(1 year)
  • plasma brain natriuretic peptide(1 year)

研究者

发起方
Shenyang Northern Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Han Yaling, MD

vice president

Shenyang Northern Hospital

研究点 (1)

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