ISRCTN64894118已完成未知
A 12-week, randomised, double-blind study evaluating the effects of low-dose (10 mg) and high-dose (80 mg) atorvastatin on macrophage activity and carotid plaque inflammation as determined by ultra small super-paramagnetic iron oxide (USPIO) enhanced carotid magnetic resonance imaging (MRI)
GlaxoSmithKline (UK)0 个研究点目标入组 40 人开始时间: 2006年3月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19477353 (added 10/09/2019) 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21483158
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- •1. Signed written informed consent prior to beginning study-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study)
- •2. Male or female aged 18 to 80 years of age at screening. Female subjects must be of non-childbearing potential (post-menopausal females who have been amenorrheic >1 year, or pre-menopausal females with a documented hysterectomy or bilateral oophorectomy).
- •3. Positive USPIO-enhanced MRI of carotid plaque confirmed by a consultant neuroradiologist. This will be pre-defined.
- •4. Must either be statin naive or have been on a stable dose of a statin for =4 weeks prior to screening, with no evidence of statin intolerability
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Required continued use of non-statin lipid modifying therapies
- •2. History of statin intolerance
- •3. History of chronic viral hepatitis or other chronic hepatic disorders
- •4. Renal impairment
- •5. History of myopathy or inflammatory muscle disease
- •6. Doppler assessment of less than 40% stenosis during screening assessment
- •7. Contraindication to MRI scanning
- •8. Planned carotid surgery or endovascular intervention earlier than 10 weeks within the study period
- •9. Serum triglycerides >400 mg/dl (4.52 mmol/l) at screening
- •10. Patients with poorly controlled diabetes mellitus and hypertension
- •11. History of malignancy
- •12. Evidence of recent severe infection
- •13. Current life-threatening condition other than vascular disease
- •14. Alcohol or drug abuse within the past six months
- •15. Concomitant use of potent CYP450 3A4 inhibitors
- •16. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) and oral steroids therapy
- •17. Chronic use of immunosuppressants
- •18. Use of an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication
- •19. Any other subject the investigator deems unsuitable for the study (e.g. due to either medical reasons, laboratory abnormalities, expected study medication non-compliance, or subject?s unwillingness to comply with all study-related procedures)
- •20. Inability to give informed consent
研究者
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