NCT00587717已完成不适用
The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 主要终点
- This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
研究概览
简要总结
This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing carotid endarterectomy
- •No previously known side effects of statins
- •Patients who will sign an informed consent
- •Age > 18 years old
- •No signs of current infection
排除标准
- •Patient hypersensitive to any component of this medication
- •Patients with acute liver disease (AST> normal value)
- •Patients with chronic liver disease (history of Hepatitis B or C)
- •Patients with renal failure (creatinine > 3.0)
- •Patients with unexplained muscle pains and aches
- •Patients with rheumatoid arthritis
- •Patients with Lupus
- •Current cancer treatment
- •Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
- •Pregnant females
研究组 & 干预措施
1
Active Comparator
Two 80 mg pills simvastatin taken 24 hours prior to surgery
干预措施: simvastatin (Drug)
2
Placebo Comparator
Two 80 mg pills placebo are taken 24 hours prior to surgery
干预措施: placebo (Drug)
结局指标
主要结局
This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
时间窗: 24 prior to surgery
次要结局
未报告次要终点
研究者
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