Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI): A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Average monthly enrollment rate
研究概览
简要总结
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.
This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years
- •Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician)
- •Written informed consent
排除标准
- •Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)
- •Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
- •Known hypersensitivity to colchicine
- •Serious gastrointestinal disease (severe gastritis or diarrhea)
- •Clinically overt hepatic disease
- •Severe renal disease (eGFR< 30ml/min/1.73m2)
- •Clinically significant blood dyscrasia (e.g., myelodysplasia)
- •Absolute indication for or ongoing treatment with colchicine
- •Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
研究组 & 干预措施
Intervention
Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
干预措施: Colchicine 0.6 mg (Drug)
Control
Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
干预措施: Matching placebo (Drug)
结局指标
主要结局
Average monthly enrollment rate
时间窗: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Average number of patients enrolled per month
Compliance with study treatment
时间窗: From randomization until 10 days after catheter ablation
Number of provided capsules taken (measured as a proportion of 20 capsules)
Rate of complete follow-up at 6 months
时间窗: From inception until completion of the study
This will describe the rate of patients for whom the 6-month follow visit can be completed
次要结局
- Rate of signs and symptoms of pericarditis(From randomization until 10 days after catheter ablation)
- Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation(From randomization until 2 weeks after catheter ablation for atrial fibrillation)
- Rate of non-infectious diarrhea(From randomization until 10 days after catheter ablation)
- Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation(Between week 10 and 15 after catheter ablation for atrial fibrillation)
- Rate of all-cause mortality(Through study completion (estimated to be up to 24 months))
- Rate of patients with composite clinical endpoint(Through study completion (estimated to be up to 24 months))