Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization)
研究概览
简要总结
Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years and 80 years of age.
- •The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
- •The patient or guardian agrees to the study protocol and provides informed, written consent.
排除标准
- •Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
- •Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
- •The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
- •History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
- •Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)
- •The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
- •The patients who might die of other disease than cardiac disease during the trial.
研究组 & 干预措施
High dose Atorvastatin 80 mg
Administered Atorvastatin 80 mg before intervention
干预措施: Atorvastatin (Drug)
Control
Administered Atorvastatin 10 mg before intervention
干预措施: Atorvastatin (Drug)
结局指标
主要结局
To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization)
时间窗: 30 days
次要结局
- To evaluate the safety of high dose atorvastatin in STEMI - TIMI flow at before and after PCI - Myocardial blush grade after PCI - Procedural success (No reflow incidence) - MACE at 6 month - Periprocedural MI(immediate, 30 days, 6 months)