NCT00352417已完成2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Effects of VIA-2291, a 5-Lipoxygenase Inhibitor, on Atherosclerotic Plaque and Biomarkers of Vascular Inflammation in Patients With Carotid Stenosis Undergoing Elective Carotid Endarterectomy
Tallikut Pharmaceuticals, Inc.3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Percent Cross-sectional Area of Macrophages in Plaque Tissue
研究概览
简要总结
This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients must be of non-childbearing potential
- •Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery
- •One or more of the following clinical features: Prior history >4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time
- •Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting blood glucose levels >6.9 mmol/L
- •Baseline hsCRP >2 mg/L
- •Echolucent plaque
排除标准
- •Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy
- •Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
- •Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
- •Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c >11% at screening
- •Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
- •Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery (within 4 weeks of enrollment)
- •Current atrial fibrillation
- •Planned cardiac intervention
- •Acetaminophen use in any form in the 7 days before enrollment
研究组 & 干预措施
VIA-2291
Experimental
干预措施: VIA-2291 (Drug)
Placebo
Placebo Comparator
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Cross-sectional Area of Macrophages in Plaque Tissue
时间窗: 12 weeks
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody
次要结局
- Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue(12 weeks)
- Change From Baseline in Whole Blood Leukotriene B4 Production(Baseline and 12 weeks)
- Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine(Baseline and 12 Weeks)
- Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)(Baseline and 12 weeks)
研究者
研究点 (3)
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