Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- MACEs
研究概览
简要总结
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.
详细描述
Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:
- group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour.
N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.) 2. control group of patients. Number of patients according to sample size equation.
Sample size equation is used to calculate the minimum size of the required sample:
n = (z)2 p (1- p) / d2
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
- •PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
- •PPMI (rise in post-PCI troponin plus new evidence of ischemia).
排除标准
- •Patients with active infections.
- •Patients taking anti-inflammatory medications.
- •Patients presented with ACS( still rising troponin).
- •Severe renal impairment ( creatinine clearance < 45 ml/min ).
- •Primary PCI, rescue PCI, pharmacoinvasive therapy.
- •Connective tissue diseases.
研究组 & 干预措施
colchicine group
干预措施: Colchicine Pill (Drug)
结局指标
主要结局
MACEs
时间窗: one month
Major Adverse Cardiac Events
次要结局
未报告次要终点