Anti-inflammatory Therapy During Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 1
- 主要终点
- Number of Participants With Peri-procedural Myocardial Necrosis
研究概览
简要总结
Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.
详细描述
The investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. The investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for possible PCI
排除标准
- •Colchicine use within 1 month
- •History of colchicine intolerance
- •Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
- •Active malignancy or infection (major confounder with increased inflammatory markers)
- •History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
- •High-dose statin load <24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)
- •Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug
- •Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)
- •Unable to consent
- •Participating in a competing study
- •Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures
研究组 & 干预措施
Colchicine
Colchicine 1.8 mg PO over 1 hour
干预措施: Colchicine vs Placebo (Drug)
Placebo
Matching placebo
干预措施: Colchicine vs Placebo (Drug)
结局指标
主要结局
Number of Participants With Peri-procedural Myocardial Necrosis
时间窗: 24 hours
troponin above the upper limit of normal (ULN)
次要结局
- Number of Participants With All-cause Mortality, Non-fatal MI, or TVR(1 year)
- All-cause Mortality, Non-fatal MI, or TVR(5 years)
- Number of Participants With Peri-procedural Myocardial Infarction (MI)(24 hours)
- Number of Participants With All-cause Mortality, Non-fatal MI, or Target Vessel Revascularization (TVR)(30 days)