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临床试验/NCT01975194
NCT01975194终止4 期

Use of Rosuvastatin to Achieve Lipid Targets in African American Subjects With Cerebrovascular Disease

Wayne State University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
20
试验地点
1
主要终点
LDL value

研究概览

简要总结

This study will assess the rate at which rosuvastatin will achieve LDL targets in African American patients with previous history of stroke or TIA.

详细描述

Background:

Blacks have twice the risk of stroke compared to Whites and a recent analysis found that stroke incidence was decreasing in Whites but not Blacks. Identifying new avenues for stroke prevention is important in African Americans.

The Stroke Prevention through Aggressive Reduction of Cholesterol Levels (SPARCL) trial showed that treatment with atorvastatin 80 mg/d reduced the frequency of stroke by 16%. In the SPARCL trial, the mean low density lipoprotein-cholesterol (LDL-C in the treatment group was 73 mg/dl. On the basis of the SPARCL trial, the American Stroke Association now recommends statins with "intensive lipid lowering effects" for secondary prevention in the 2008 guideline update. Achieving target levels is most important for secondary prevention of stroke, when patients have an annual risk of stroke recurrence of 3-15% per year. Rosuvastatin is well suited for these secondary prevention goals due to its potent lipid-lowering effects.

Objectives

The objectives of this study are to establish the following:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30 and above
  • Rankin score of ≤ 3
  • Patient has a fixed telephone number and is available for follow-up
  • African American
  • Diagnosis of ischemic stroke or TIA in past 12 months

排除标准

  • Liver enzyme abnormalities (ALT or AST >2x ULN)
  • Known muscle disorder or CK > 5x ULN
  • Alcoholism or substance abuse
  • Stroke due to dissection or hypercoagulable state
  • Moderate to severe dementia (MMSE <20)
  • On hemodialysis
  • No fixed home address

研究组 & 干预措施

Rosuvastatin

Experimental

Patients that receive rosuvastatin

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

LDL value

时间窗: three months

LDL value recorded three months after study entry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seemant Chaturvedi

Professor of Neurology

Wayne State University

研究点 (1)

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