Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinically Significant Atrial Fibrillation
研究概览
简要总结
The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung.
排除标准
- •In AF prior to surgery*,
- •Undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion, needle pleural/lung biopsies, or minor chest-wall surgeries), or
- •With contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or estimated glomerular filtration rate [e-GFR] <30 mL/min/1.73m)
- •Clarification: Patients with history of AF who are in sinus rhythm during enrollment will be eligible for recruitment. Patients who have no history of AF and are found to be in AF at the time of enrollment will not be eligible.
研究组 & 干预措施
Active Colchicine
On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
干预措施: Colchicine 0.6 mg (Drug)
Placebo Colchicine
On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
干预措施: Placebo Colchicine (Drug)
结局指标
主要结局
Clinically Significant Atrial Fibrillation
时间窗: Post-operative Day 1 until Postoperative Day 30
New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds.
次要结局
- Death(Post-operative Day 1 until Postoperative Day 30)
- New Onset Atrial Flutter(Post-operative Day 1 until Postoperative Day 30)
- Transient Ischemic Attack (TIA)(Post-operative Day 1 until Postoperative Day 30)
- Post-operative Infection(Post-operative Day 1 until Postoperative Day 30)
- Myocardial Injury After Non-Cardiac Surgery (MINS)(Post-operative Day 1 until Postoperative Day 30)
- Stroke(Post-operative Day 1 until Postoperative Day 30)