the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
研究概览
简要总结
The purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.
详细描述
Patients with stable angina and hyperuricemia who undergo percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) are enrolled. Participants will be randomly assigned to one of the two treatment groups.
Febuxostat group and A lifestyle modification group. At 8-12 months, routine follow up angiography and IVUS interrogation as well as endothelial function and several bio markers will be assessed.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 20 years of age or older at enrollment who are able to visit
- •Patients with chronic stable angina who have severe coronary stenosis wich require PCI.
- •Patients who have at least one coronary plaque (≧ 500μm in thickness or % plaque of 20% or more) at the non-culprit vessels.
- •Patients with hyperuricemia, who have a serum uric acid level >7.0mg/dL within 2 months prior to enrollement.
- •Patients who personally given written informed consent to participate in this study.
排除标准
- •Patients who had undergone previous PCI for the lesion under investigation.
- •Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment.
- •Patients with a previous history of hypersensitivity to febuxostat or allopurinol.
- •Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73m2, etc.
- •Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal.
- •Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine.
- •Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat.
- •Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study.
研究组 & 干预措施
Febuxostat treatment group
once daily after breakfast
干预措施: Febuxostat (Drug)
结局指标
主要结局
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
时间窗: 8-12
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
时间窗: 8-12 months
次要结局
- prognosis(death, ACS, restenosis)(8-12 months)
- changes in plaque characteristics assessed by IVUS from baseline to follow up(8-12 months)
- changes in serum uremic values and inflammatory markers from baseline to follow up(8-12 months)
- absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up(8-12 months)
- absolute changes of coronary plaque volume by IVUS from baseline to follow up(8-12 months)
- nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up(8-12 months)
- nominal changes in plaque burden assessed by IVUS from baseline to follow up(8-12 months)
研究者
Kiyoshi Hibi
associate professor of medicine
Yokohama City University Medical Center