NCT02995512撤回4 期
Mechanistic Effects of Colchicine in Patients With Myocardial Infarction A Single Center Phase 4 Single Arm Open-label Study Evaluating the FDA-approved Drug, Colchicine, at the FDA-approved Gout Dose in Patients With Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of neutrophils adherent to TNFα-stimulated endothelial cells
研究概览
简要总结
The aim of this study is to determine the immuno-modulatory mechanistic effects of colchicine in patients with myocardial infarction (MI). Investigators hypothesize that colchicine exerts its anti-inflammatory properties by switching the metabolism of neutrophils, thereby reducing the expression of adhesion molecules responsible for their recruitment in MI.
详细描述
This is a pilot study to explore the mechanistic effects of colchicine in patients with MI. The study will be conducted sequentially in 3 parts:
- Blood will be collected from up to 10 healthy volunteers for protocol development. (Group 1).
- Blood will be collected from 20 MI patients within 24 hours of presentation at New York University (NYU) Langone Medical Center and Bellevue Hospital Center (BHC). Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism, using a Seahorse Analyzer will be evaluated pre- and post-addition of in vitro colchicine. (Group 2)
- The standard low-dose loading regimen of colchicine (1.2 mg followed by 0.6 mg one hour later) will be administered to 20 patients with MI at BHC. Blood will be collected prior to drug administration, 2 to 3 hours after completion of the colchicine load, and 23 to 24 hours after the completion of the colchicine load. Neutrophil adhesion to human aortic endothelial cells, quantitative expression of adhesion molecules on the surface of neutrophils, quantitative levels of adhesion molecules on neutrophils and endothelial cells, and neutrophil metabolism will be evaluated pre- and post-addition of in vitro colchicine (exact markers will be determined based on the results of in viro studies above). (Group 3)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •18 years of age for the healthy volunteer subset.
- •18 years of age and within 24 hours of an MI for the MI subset.
排除标准
- •Subjects in all 3 groups will be excluded if they meet one of the following criteria
- •history of myelodysplasia;
- •Use of anti-inflammatory medications, with the exception of aspirin, within 5 half-lives;
- •medications known to interact with colchicine;
- •known creatinine clearance <30 cc/minute (severe kidney disease);
- •pregnant; or
- •Unable to consent.
- •MI subjects who will have oral colchicine administered will have the following additional exclusion criteria:
- •history of intolerance to colchicine;
- •acute or chronic symptoms of diarrhea within 72 hours prior to enrollment;
- •hemoglobin <10 g/dL or clinical evidence of active bleeding during the study period.
研究组 & 干预措施
Myocardial Infarction (MI) Patients
Experimental
干预措施: Colchicine 0.6 mg tablets (Drug)
结局指标
主要结局
Number of neutrophils adherent to TNFα-stimulated endothelial cells
时间窗: 1 Day
Metabolism of neutrophils will be measured using the Seahorse assay.
次要结局
- Expression of adhesion molecules on the surface of neutrophils assessed via flow cytometry(1 Day)
- Measures of neutrophil metabolism (e.g. O2 consumption)(1 Day)
- Levels of adhesion molecules on neutrophils and endothelial cells quantified using PCR(1 Day)
研究者
相似试验
已完成
2 期
The Effects of Standard Protocol With or Without Colchicine in Covid-19 InfectionCOVID-19NCT04360980Shahid Beheshti University of Medical Sciences80
已完成
2 期
Colchicine Counteracting Inflammation in COVID-19 PneumoniaCoronavirus InfectionsPneumonia, ViralNCT04322565Azienda Ospedaliero-Universitaria di Parma193
招募中
3 期
Colchicine Protective Effect in Patients Undergoing Percutaneous Coronary Intervention (COLCHICINE-PROTECT)Coronary Artery DiseaseNCT05739929Helwan University400
已完成
2 期
Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory ResponseAcute Myocardial InfarctionNCT02363725University Hospital, Montpellier44
已完成
3 期
The Effect of Colchicine on Inflammation in ACS PatientsAcute Coronary SyndromeSTEMINCT06054100Ain Shams University88
