Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,095
- 试验地点
- 2
- 主要终点
- serum level of high sensitive CRP
研究概览
简要总结
Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.
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 filled in by the patient.
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: Statin (Drug)
结局指标
主要结局
serum level of high sensitive CRP
时间窗: until the last day of the next February after 5-year follow-up survey
次要结局
- recurrent stroke(until the last day of the next February after 5-year follow-up survey)