Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation (statin)
Effects of High-dose Statin Treatments on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Drug-eluting Stents Implantation: a Randomized Controlled Study
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.
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Myeong-Ki Hong, MD,PhD
- 电话号码:+82 2 2228 8458
- 邮箱:mkhong61@yuhs.ac
研究联系人备份
- 姓名:Byeong-Keuk Kim, MD,PhD
- 电话号码:+82 2 2228 8465
- 邮箱:kimbk@yuhs.ac
学习地点
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Seoul、大韩民国
- 招聘中
- Hong Myeong-Ki
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接触:
- Myeong-Ki Hong, MD.PhD
- 电话号码:+82 2 2228 8458
- 邮箱:mkhong61@yuhs.ac
-
首席研究员:
- Myeong-Ki Hong, MD.PhD
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接触:
- Byeong-Keuk Kim, MD.PhD
- 电话号码:+82 2 2228 8465
- 邮箱:kimbk@yuhs.ac
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Atorvastatin group
Atorvastatin 40 mg daily for 12 months after randomization
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Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
其他名称:
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有源比较器:Pravastatin group
Pravastatin 20mg daily for 12 months after randomization
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Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program Pravastatin 20mg daily for 12 months after randomization |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
the composite of death from any cause
大体时间:12 months after randomization
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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.
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12 months after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
cardiac or non-cardiac death
大体时间:12month
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12month
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合作者和调查者
调查人员
- 首席研究员:Myeong-Ki Hong, MD.PhD.、Severance Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 4-2010-0298
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Atorvastatin (High dose statin treatment)的临床试验
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Jiangsu Province Centers for Disease Control and...Academy of Military Medical Sciences,Academy of Military Sciences,PLA; ZHONGYIANKE Biotech Co... 和其他合作者招聘中