Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)
研究概览
简要总结
The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.
详细描述
The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dyslipidemia as defined by any of the parameters:
- •HDL-C < 50 mg/dL
- •LDL-C ≥ 140 mg/dL
- •LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement
- •Patients who passed three months or more after acute myocardial infarction
- •Patients who passed one month or more after unstable angina
- •Patients who passed one month or more after PCI
- •Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial
排除标准
- •Patients with any allergy to pitavastatin or atorvastatin
- •Patients with familial hypercholesterolemia
- •Patients receiving pitavastatin
- •Patients with severe hypertension
- •Patients with renal disorders or undergoing dialysis
- •Patients with hepatobiliary disorders
- •Patients with hepatobiliary disorders
- •Patients with family history of hypothyroidism or muscular dystrophy
- •Patients with history of drug-induced hepatic disorder
- •Drug abuser or dipsomaniac
- •Patients with cardiogenic shock.
- •Patients who hopes for pregnancy during this study
- •Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin
- •Patients who are ineligible in the opinion of the investigator
研究组 & 干预措施
1
pitavastatin group
干预措施: Pitavastatin (Drug)
2
atorvastatin group
干预措施: Atorvastatin (Drug)
结局指标
主要结局
HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)
时间窗: start, 6 months, 12 months, 30 months
次要结局
- TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ(start, 6 months, 12 months, 30 months)
研究者
Hisao Ogawa
Kumamoto University
Kumamoto University