Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in Acute Myocardial Infarction (AMI) Patients With Abnormal Glucose Metabolism: a Multicenter Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- HbA1c reduction
研究概览
简要总结
Different types of statins show different influences on glycometabolism. There are no systemic analyses of the effects that statins exert on the metabolism of glucoses so far in China. This research aims to compare impacts on the glycometabolism of pitavastatin in AMI patients with atorvastatin and to accumulate data for guiding the utilization of statins.
详细描述
General study design:
This study is a prospective, multicenter, open and randomized controlled clinical trial, which utilize online registration database of CAMI to do the enrollment, randomization and follow-up. We will select 14 of the centers to compete into the group. The researchers used a central randomized distribution system to prescribe medication for patients. Follow the method of drug administration approved by the state drug administration department, we will estimate the efficacy and safety of treatment at the following timing: baseline, one month and six months after treatment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed acute myocardial infarction.
- •Diabetes or pre-diabetes.
- •The patient signed informed consent.
排除标准
- •A clear history of chronic liver disease, or abnormal liver function (ALT/AST>1.5×ULN).
- •There is evidence of active inflammatory myopathy or CK>3×ULN.
- •Being allergic to statins or severe side effects were caused by taking statins(including myolysis).
- •Combined with hypothyroidism, nephrotic syndrome, alcoholism, pancreatitis, lupus erythematosus.
- •All patients who had a clear adverse reaction to the statins.
- •Possibility of pregnancy, pregnant or lactating patients.
- •There may be limited medical history of subjects who may can not complete their treatment during the study period.
- •Undergoing or planning to functional renal transplantation.
- •The life expectancy is no more than half a year.
- •Patients who are taking birth control pills, steroid hormones and imidazole drugs.
- •Patients who have participated in clinical trials of other drugs within 1 month, or known that clinical follow-up or research on drug compliance poorly.
- •Patients are not fit to be tested according to the researchers.
研究组 & 干预措施
Pitavastatin
Patients diagnosed AMI with abnormal glucose metabolism use pitavastatin (4mg po Qn) to control cholesterol for 6 months.
干预措施: Pitavastatin (Drug)
Atorvastatin
Patients diagnosed AMI with abnormal glucose metabolism use atorvastatin (20mg po Qn) to control cholesterol for 6 months.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
HbA1c reduction
时间窗: six months after treatment
Comparing the impact on HbA1c of AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg
次要结局
- LDL-c reduction(six months after treatment)
研究者
Yuejin Yang
Vice President of Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital