The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.
研究概览
简要总结
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Subjects with >= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy
- •Age >= 18 years
- •Agreement of the operating surgeon for patient to participate
排除标准
- •Surgery scheduled < 14 days after randomization
- •Pregnancy
- •ALT, GGT > 3x upper limit of normal (ULN)
- •Creatinine > 3.5 mg/dL
- •Prior intolerance to statins
- •Reluctance to add or change dosage of statin therapy during study
研究组 & 干预措施
Drug: Fasudil hydrochloride
Fasudil hydrochloride 40 mg three times a day X 14 days
干预措施: Fasudil Hydrochloride (Drug)
Drug: Placebo oral tablet
Placebo 1 tablet three times daily x 14 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.
时间窗: >= 2 weeks
We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo.
次要结局
未报告次要终点
研究者
Anju Nohria
Associate Physician in Internal Medicine
Brigham and Women's Hospital