NCT05705804招募中不适用
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks
研究概览
简要总结
The purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dyslipidemia
- •Patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion)
- •Patients with metabolic syndrome but without diabetes
排除标准
- •Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year
- •Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal
- •Allergy or hypersensitivity to statins or ezetimibe
- •Solid organ transplant recipients
- •History of side effects requiring discontinuation of statin administration
- •Pregnant women, potentially pregnant or lactating women
- •Life expectancy less than 3 years
- •If it is judged that follow-up for more than 1 year is not possible
- •If the patient is unable to understand or read the consent form
研究组 & 干预措施
Group PE
Experimental
Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
干预措施: Pitavastatin plus Ezetemibe (Drug)
Group P
Experimental
Pitavastatin 4mg group
干预措施: Pitavastatin (Drug)
Group A
Active Comparator
Atorvastatin 40 mg administration group
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks
时间窗: At 24 weeks
Changes of homeostatic model assessment for insulin resistance (HOMA-IR) form baseline to 24 weeks will be compared among the three groups.
次要结局
- Changes of fasting glucose at 24 weeks(At 24 weeks)
- Changes of insulin at 24 weeks(At 24 weeks)
- Changes of HbA1c at 24 weeks(At 24 weeks)
- LDL-cholesterol change at 24 weeks(At 24 weeks)
- Proportion of HbA1C ≥6.5%(At 24 weeks)
- Proportion of new-onset diabetes mellitus(At 24 weeks)
- Changes of HOMA-β at 24 weeks(At 24 weeks)
- Proportion of fasting glucose ≥100 mg/dL(At 24 weeks)
- Changes of triglyceride at 24 weeks(At 24 weeks)
- HDL-cholesterol change at 24 weeks(At 24 weeks)
研究者
研究点 (1)
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