Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 8
- 主要终点
- Postpericardiotomy syndrome
研究概览
简要总结
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
详细描述
The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.
Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients in the third day after a cardiac surgery operation
- •Age≥ 18 years
- •Informed consent
排除标准
- •All evaluated before the surgical operation:
- •Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
- •Serum creatinine >2.5 mg/dl
- •Serum creatine kinase (CK) over the upper limit of normality or known myopathy
- •Known gastrointestinal or blood disease
- •Pregnant or lactating women or women not protected by a contraception method
- •Known hypersensibility to colchicine
- •Treatment with colchicine at enrolment
结局指标
主要结局
Postpericardiotomy syndrome
时间窗: 12 months
次要结局
- Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses