NCT00361530已完成3 期
Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon Carotid Intima-media Complex Thickness in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan2 个研究点 分布在 1 个国家目标入组 854 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 854
- 试验地点
- 2
- 主要终点
- Intima-media complex thickness (IMT) of the common carotid artery (CCA)
研究概览
简要总结
Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with prescription of pravastatin and the control.
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
- •Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
- •Patients after carotid endarterectomy or radiation therapy to neck
- •Patients whose carotid ultrasound cannot be examined because of neck tumor or torticollis
- •Patients after carotid endarterectomy or radiation therapy to neck
研究组 & 干预措施
Pravastatin
Active Comparator
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
Intima-media complex thickness (IMT) of the common carotid artery (CCA)
时间窗: until the last day of the next February after 5-year follow-up survey
次要结局
- Plaque score, number of plaque, recurrent cerebrovascular events(until the last day of the next February after 5-year follow-up survey)
研究者
研究点 (2)
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