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临床试验/NCT03735134
NCT03735134Unknown不适用

Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Occurrence of PPMI post elective PCI

研究概览

简要总结

The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients hospitalized with troponin negative events and scheduled for elective PCI

排除标准

  • Significant renal dysfunction
  • Significant liver dysfunction
  • Severe left ventricular dysfunction
  • Severe low weight
  • Chronic colchicine treatment

研究组 & 干预措施

Control Group

Active Comparator

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment

干预措施: Standard of care treatment prior to elective PCI (Drug)

Early colchicine loading dose

Active Comparator

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI

干预措施: Colchicine Loading Dose (Drug)

Late colchicine loading dose

Active Comparator

Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI

干预措施: Colchicine Loading Dose (Drug)

结局指标

主要结局

Occurrence of PPMI post elective PCI

时间窗: 24 hours post PCI

Occurrence of PPMI post elective PCI and its relation to defensin levels

次要结局

  • Traditional inflammatory markers(24 hours post PCI)
  • Major adverse cardiovascular events(30 days)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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