Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Occurrence of the composite of death from any cause
研究概览
简要总结
Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties. In addition, previous reports showed that trimetazidine was effective in reducing intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the evaluation of these combination effects of statin and trimetazidine on patients with aspirin monotherapy who had previously received CABG and were free of the major adverse cardiac events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that atorvastatin 40mg/day would be more effective in the prevention of the further late adverse cardiac and cerebrovascular events than other statin. To test this hypothesis, the investigators will perform a multi-center, randomized, prospective trial aimed at demonstrating the superiority of combination of high dose atorvastatin therapy and trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG surgery in real world practice.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had previously received CABG 12 months ago
- •Patients who were free of death, MI or repeat revascularization within first 12 months after CABG
- •Patients with mono antiplatelet therapy with aspirin alone
- •Age of 20 years or older
- •Patients with signed informed consent
排除标准
- •History of DES or BMS implantation within 12 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
Pravastatin group
干预措施: Pravastatin 20mg/day for 12 months after randomization (Drug)
Combination of Atorvastatin and trimetazidine group
干预措施: Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization (Drug)
结局指标
主要结局
Occurrence of the composite of death from any cause
时间窗: 12 months
次要结局
未报告次要终点