Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,578
- 试验地点
- 1
- 主要终点
- Incidence Rate of Stroke and TIA
研究概览
简要总结
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- •Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- •Able to visit outpatient department
- •Informed consent on the form.
排除标准
- •Ischemic stroke of other determined cause according to the TOAST classification
- •Ischemic heart disease and necessary to use statin
- •Hemorrhagic disorders
- •Platelet count <=100,000/ul within 3 months prior to study start
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
- •Serum creatinine >=2.0mg/dl within 3 months prior to study start
- •A scheduled operation
- •The presence of malignant disorder
研究组 & 干预措施
Pravastatin
Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Incidence Rate of Stroke and TIA
时间窗: up to 5 years
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
次要结局
- Incidence Rate of Lacunar Infarction(up to 5 years)
- Incidence Rate of Cardioembolic Infarction(up to 5 years)
- Incidence Rate of Intracranial Hemorrhage(up to 5 years)
- Incidence Rate of Atherothrombotic Infarction(up to 5 years)