Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- the composite of death from any cause
研究概览
简要总结
The purpose of this study is to determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design.
详细描述
Objective
To determine whether high dose statin therapy in patients with aspirin mono antiplatelet therapy who had received drug-eluting stent (DES) previously and were free of the adverse cardiac events during the first 12 months could be superior over pravastatin therapy in the prevention of late adverse cardiac and cerebrovascular events during the additional 12 months.
Study Design
- Prospective, randomized, multi-center study of each 1000 subjects enrolled.
- Eligible subjects will be randomized 1:1 to a) atorvastatin 40 mg (n=1000) vs. b) pravastatin 20 mg/day (n=1000). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
- Subjects with coronary artery diseases who meet all inclusion and exclusion criteria will be included Clinical and laboratory follow-up should be performed.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had previously received DES at least 12 months(±2month) ago
- •Patients who were free of death, MI, stroke, repeat revascularization, or ST within first 12 months after DES implantation
- •Patients with mono antiplatelet therapy with only aspirin after
- •Age 20 years of older
- •Patients with signed informed consent
排除标准
- •History of DES or BMS implantation within 10 months
- •Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
- •Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
- •Pregnant women or women with potential childbearing
- •Life expectancy ≤ 2 year
研究组 & 干预措施
Atorvastatin group
Atorvastatin 40 mg daily for 12 months after randomization
干预措施: Atorvastatin (High dose statin treatment) (Drug)
Pravastatin group
Pravastatin 20mg daily for 12 months after randomization
干预措施: Pravastatin (High dose statin treatment) (Drug)
结局指标
主要结局
the composite of death from any cause
时间窗: 12 months after randomization
Occurrence of the composite of death from any cause, MI, target vessel revascularization (TVR, either by PCI or CABG), non-TVR, stent thrombosis (ST), peripheral artery intervention, deterioration of renal function, stroke or admission for significant clinical cardiac events for 12 months following the randomization to the assigned statin therapy.
次要结局
- cardiac or non-cardiac death(12month)
研究者
Myeong-Ki Hong
Professor of cardiology
Yonsei University