Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,209
- 试验地点
- 44
- 主要终点
- Clinically important perioperative atrial fibrillation/atrial flutter
研究概览
简要总结
The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major thoracic surgery. Data from cardiac surgery patients suggest that prevention of perioperative atrial fibrillation using an anti-inflammatory agent, such as colchicine, is feasible. The COP-AF trial will assess whether the administration of oral colchicine will reduce the incidence of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery.
详细描述
Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are among the most common serious complications occurring after thoracic surgery. AF is the most common perioperative cardiac arrhythmia. The incidence of perioperative AF in patients undergoing major thoracic surgery ranges from 10% in low-risk patients to as high as 20% in high-risk patients. The course of patients with perioperative AF is frequently complicated by hemodynamic instability, problems with managing anticoagulation in the early postoperative period, prolonged intensive care unit and hospital stays, and increased costs. Patients who develop perioperative AF (POAF) or MINS also have a significantly increased risk of death and stroke.
Colchicine is an inexpensive drug and a highly effective anti-inflammatory agent that holds great potential for preventing POAF and MINS in patients undergoing thoracic surgery. Data from cardiac surgery patients suggest that prevention of POAF using colchicine is feasible, but whether this concept is also applicable to patients undergoing thoracic surgery, where the risk of POAF is lower and underlying mechanisms may be different, is currently unclear. The 'Colchicine for the prevention of perioperative AF' (COP-AF) trial has been designed as a large randomized, double blind, placebo controlled trial to determine whether colchicine, a potent, safe and inexpensive anti-inflammatory drug, lowers the risk of perioperative AF, MINS, and other inflammatory complications in patients undergoing thoracic surgery. The primary objective of this trial is to determine whether a 10-day course of colchicine 0.5mg twice daily reduces the incidence of perioperative AF and MINS within 14 days after thoracic surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible if they:
- •are undergoing thoracic surgery with general anesthesia;
- •are greater than or equal to 55 years of age at the time of randomization;
- •are expected to require at least an overnight hospital admission after surgery; and
- •provide written informed consent to participate.
排除标准
- •Patients will be excluded if they:
- •have a prior history of documented atrial fibrillation;
- •are currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
- •are undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
- •have a contraindication to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate less than 30 mL/min/1.73m);
- •are not expected to take oral medications for greater than 24 hours after surgery (e.g., esophagectomy);
- •are scheduled for lung transplantation;
- •are currently taking non-study colchicine before surgery;
- •have severe hepatic dysfunction;
- •have aplastic anemia;
- •are a woman of childbearing potential who is pregnant, breastfeeding, or not taking effective contraception;
- •took within the last 14 days or are scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole, or itraconazole;
- •are an HIV patient treated with antiretroviral therapy; or
- •are scheduled for thoracoscopic lung wedge resection only.
研究组 & 干预措施
Colchicine
Participants received over-encapsulated colchicine 0.5 mg tablet orally twice daily for 10 days.
干预措施: Colchicine (Drug)
Placebo
Participants received matching placebo capsules orally twice daily for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinically important perioperative atrial fibrillation/atrial flutter
时间窗: 14 days of randomization
Myocardial injury after noncardiac surgery
时间窗: 14 days of randomization
次要结局
- First occurrence of myocardial infarction(14 days of randomization)
- First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke(14 days of randomization)
- Time to chest tube removal(14 days of randomization)
- Duration of stay in ICU, step-down, and in-hospital(14 days of randomization)
- First occurrence of the composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, or nonfatal stroke(14 days of randomization)
- First occurrence of myocardial injury after noncardiac surgery not fulfilling the 4th universal definition of myocardial infarction(14 days of randomization)