跳至主要内容
临床试验/NCT07143136
NCT07143136招募中1 期

Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.

Assiut University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月10日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
140
试验地点
1
主要终点
Incidence of MACE (composite of cardiovascular death, non-fatal MI, stroke, urgent revascularization) at 30 days and 6 months.

研究概览

简要总结

Inflammation plays a central role in the pathophysiology of atherosclerosis and in the progression of coronary artery. Colchicine, an anti-inflammatory agent traditionally used for gout and pericarditis, has emerged as a potential therapy in cardiovascular disease due to its ability to inhibit microtubule polymerization and suppress interleukin-1β and the NLRP3 inflammasome pathway.

COLCOT and LoDoCo2 trails have demonstrated the efficacy of colchicine in reducing cardiovascular events in patients with coronary artery disease.

However, more recent trials, including OASIS 9 and COVERT-MI trials did not support the use of a short-term colchicine treatment at the acute phase of ST segment elevation myocardial infarction (STEMI) to reduce infarct size and improve outcomes. Limited data exist on the peri-procedural use of colchicine in non-ST elevation myocardial infarction patients undergoing PCI.

This study proposes to assess whether a loading dose of colchicine before PCI, followed by 3-months maintenance therapy, can improve short-term clinical outcomes and inflammatory markers in non- STEMI patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Non-STEMI
  • Undergoing PCI with drug-eluting stents

排除标准

  • Severe renal or hepatic dysfunction
  • Colchicine hypersensitivity
  • Active infection and active diarrhea.
  • Gastrointestinal intolerance
  • Pregnancy or breastfeeding.
  • Cardiogenic shock

研究组 & 干预措施

Colchicine group

Active Comparator

干预措施: Colchicine (Drug)

Control group

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of MACE (composite of cardiovascular death, non-fatal MI, stroke, urgent revascularization) at 30 days and 6 months.

时间窗: 6 months

次要结局

  • Rate of gastrointestinal side effects and other colchicine-related adverse events.(3 months)
  • Change in CRP from baseline to 3 months post-PCI(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Gamal William Ibrahim

Resident Doctor

Assiut University

研究点 (1)

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