The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Effect of colchicine therapy on sST2 levels in ACS patients
研究概览
简要总结
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
详细描述
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •STEMI patients who were successfully treated with PCI.
排除标准
- •Pregnant or breast-feeding women or women of childbearing potential.
- •Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
- •Known hypersensitivity to colchicine or current chronic treatment with colchicine.
- •Severe renal failure (estimated creatinine clearance <30ml/min) or hepatic failure (Child Pugh score B or C )
- •Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
- •Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
研究组 & 干预措施
Colchicine group
Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
干预措施: Colchicine Tablets (Drug)
结局指标
主要结局
Effect of colchicine therapy on sST2 levels in ACS patients
时间窗: 3 months
sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months
次要结局
- Effect of colchicine therapy on occurrence of ischemic events in ACS patients(3 months)
- Change in serum levels of IL-1beta(3 months)
- Change in left ventricular ejection fraction(3 months)
- Lipid profile parameters and TG/HDL-C ratio(3 months)
研究者
Hanan ahmed
Principle investigator
Ain Shams University