Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 主要终点
- The Number of Participants With Colchicine Side Effects
研究概览
简要总结
This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not
详细描述
Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.
Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.
This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive adult patients undergoing elective cardiac surgery
排除标准
- •Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
- •Known severe liver disease or current transaminases >1.5 times the upper normal limit
- •Current serum creatinine >2.5 mg/dl
- •Known myopathy or elevated baseline preoperative creatine kinase
- •Known blood dyscrasias
- •Significant gastrointestinal disease
- •Pregnant and lactating women
- •Known hypersensitivity to colchicine
- •Current treatment with colchicine for any indications
- •Emergency surgery
研究组 & 干预措施
Colchicine
Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing <70 kg or intolerant to the full dose.
干预措施: Colchicine (Drug)
结局指标
主要结局
The Number of Participants With Colchicine Side Effects
时间窗: From date of randomization until the date of discharge, assessed up to 2 weeks
The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.
The Number of Participants With Atrial Fibrillation
时间窗: From date of randomization until the date of discharge, assessed up to 2 weeks
The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
次要结局
未报告次要终点