Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis, Endothelial Function, Circulating microRNAs, and Cardiovascular Events in Patients With Coronary Artery Disease Requiring Stent Implantation: OCT and NIRS Comparison
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment
研究概览
简要总结
To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.
详细描述
- Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after everolimus-eluting stent implantation with OCT and NIRS study.
- 12 months follow-up coronary angiography with OCT and NIRS will be performed to compare neointimal hyperplasia and atherosclerosis progression.
- 36 months clinical follow-up for major adverse cardiovascular events (cardiac death, all-cause death, myocardial infarction, stroke, target lesion revascularization) will be compared.
- Safety issues such as bleeding rates, abnormal liver function will be compared
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Patients between the age of 30 to 79
- •Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)
排除标准
- •Hypersensitivity to pitavastatin
- •Unable to perform OCT and NIRS
- •Serum creatinine > 2.0 mg/dL.
- •Steroid or hormone replacement therapy
- •Hemoglobin A1c >9%
- •Type 1 diabetes
- •Decreased serum platelet level (< 100,000/uL)
- •Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
- •Life expectancy less than a year
- •Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
- •Involvement in the planning and/or conduct of the study
- •Left ventricular ejection fraction < 40%
- •Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit)
- •Gastrointestinal disorder such as Crohn's disease
- •Alcohol abuse
- •Known pregnancy, breast-feeding, or intend to become pregnant during the study period
研究组 & 干预措施
Low dose 1mg pitavastatin
pitavastatin 1mg which is considered low dose statin will be administered for 36 months
干预措施: Pitavastatin 1mg (Drug)
Low dose 1mg pitavastatin
pitavastatin 1mg which is considered low dose statin will be administered for 36 months
干预措施: Placebo (Drug)
High dose 4mg pitavastatin
pitavastatin 4mg which is considered high dose statin will be administered for 36 months
干预措施: Pitavastatin 4mg (Drug)
High dose 4mg pitavastatin
pitavastatin 4mg which is considered high dose statin will be administered for 36 months
干预措施: Placebo (Drug)
结局指标
主要结局
Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment
时间窗: 12 months for OCT and NIRS
OCT will measure neointimal volume in every mm interval and will be averaged by dividing the total neointimal volume with the number of the segment analyzed. LCBI is the lipid volume index which is calculated automatically by the device, and LCBI \> 400 is considered high lipid volume.
次要结局
- Rates of major adverse cardiovascular events during 12 months follow-up(12 months for clinical events)
研究者
Soon Jun Hong
Professor
Korea University Anam Hospital