Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACEs)
研究概览
简要总结
Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.
-Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary syndrome.
Study design
- Prospective, double-blinded, single-center study of each 117 subjects enrolled
- Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively.
- Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B) Placebo (n=117).
- The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total
- All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of acute coronary syndrome, including unstable angina, acute non-ST elevation myocardial infarction
- •Age of 19 years or older
- •A need for isolated surgical myocardial revascularization
- •Patients with signed informed consent
排除标准
- •Patients with combined surgery with coronary bypass grafting
- •On-pump conversion
- •Patients with any increase in liver enzymes
- •Patients with history of liver or muscle disease.
- •Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis
- •Re-do surgery
- •Urgent/emergent surgery
研究组 & 干预措施
Rosuvastatin group
Rosuvastatin group
干预措施: Rosuvastatin (Drug)
Placebo group
Placebo group
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Major adverse cardiac events (MACEs)
时间窗: 30 days after OPCAB
Major adverse cardiac events (MACEs), which include the following: death from all causes, non-fatal myocardial infarction (MI), and repeat revascularization by percutaneous intervention or bypass surgery within 30 days after OPCAB.
次要结局
- The degree of myocardial ischemia and inflammatory(immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB)