Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study That Evaluates the Effects of Pravastatin for Acute Myocardial Infarction With LDL-Cholesterol Levels of 70-129 mg/dl
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Combination of death, non-fatal myocardial infarction, unstable angina, coronary revascularization (except anticipated revascularization before randomization), non-fatal stroke and re-hospitalization due to heart failure or other cardiac causes.
研究概览
简要总结
The purpose of the Study is to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.
详细描述
The investigators previously reported the beneficial effect of early use of low-dose pravastatin on major adverse cardiac events in patients with acute myocardial infarction and mild to moderate hypercholesterolemia in the OACIS-LIPID Study. The PRACTIC study is designed as the OACIS-LIPID II trial to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •the presence of 2 of the following 3 criteria:
- •a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
- •typical electrocardiographic changes (i.e., ST-segment elevation of >0.1 mV in ≥1 limb or 2 precordial leads, ST-segment depression >0.1 mV in ≥2 leads, abnormal Q waves, or T-wave inversion in ≥2 leads)
- •an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
- •the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission
排除标准
- •concurrent therapy with any HMG-CoA reductase inhibitor
- •previous history of the side effects associated with any HMG-CoA reductase inhibitor
- •life-threatening arrhythmia
- •severe chronic congestive heart failure
- •hepatic dysfunction
- •renal failure
- •cerebrovascular disease
- •poor controlled diabetes
- •pregnancy, lactation
- •age <20 years
- •disability of taking medicine or absence of a written informed consent
- •Patients whom the doctors consider inappropriate by any other reason
结局指标
主要结局
Combination of death, non-fatal myocardial infarction, unstable angina, coronary revascularization (except anticipated revascularization before randomization), non-fatal stroke and re-hospitalization due to heart failure or other cardiac causes.
时间窗: 20, 50 and 80% of the projected number of patients have been enrolled in the study
次要结局
- Each component of the primary outcome measures.(20, 50 and 80% of the projected number of patients have been enrolled in the study)