Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 254
- 试验地点
- 3
- 主要终点
- Atrial fibrillation
研究概览
简要总结
The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.
详细描述
AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.
The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 years or above undergoing elective cardiac surgery.
- •Sinus rhythm and no previous AF
- •Agreed to sign informed consent.
排除标准
- •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 or 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
Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge
干预措施: Colchicine (Drug)
Placebo Oral Tablet
Identical tablet (placebo) administered in a similar way as that in the active comparator arm
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Atrial fibrillation
时间窗: Through study completion, an average of 1 week
AF documented by EKG
次要结局
- Side effects of colchicine(Through study completion, an average of 1 week)