Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 8
- 主要终点
- Number of atrial fibrillation (AF) recurrence
研究概览
简要总结
The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.
详细描述
Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A randomization list will be provided by the Clinical Trial Unit Basel to an unblinded person at the sponsor's site. The unblinded person will allocate the randomization numbers. Patients and research staff involved in patient recruitment, data management, outcome adjudication and data analyses will fully be blinded
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
- •ECG-documented AF prior to ECV
- •Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥1 hour after ECV
- •Ability to give written informed consent
排除标准
- •AF persistence after cardioversion or early AF recurrence within 1 hour after ECV
- •Any other rhythm than AF before cardioversion
- •Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned within 3 months after ECV
- •Known intolerance or hypersensitivity to Colchicine
- •Any other absolute indication for Colchicine intake
- •Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
- •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)
- •Significant immunosuppression (e.g. due to transplantation or rheumatic disease)
- •Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
- •Life expectancy <1 year
研究组 & 干预措施
Experimental Group
Study participants in the active study arm will receive a daily oral dose of 0.5 mg Colchicine for 3 months without a loading dose. The dose is recommended to be taken in the morning. There is no deviation from the usual treatment intake.
干预措施: Colchicine (Drug)
Control Group
Study participants in the placebo group will receive a matched placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of atrial fibrillation (AF) recurrence
时间窗: within 6 month after electrocardioversion
The primary outcome of AF recurrence within 6 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG.
次要结局
- Number of survived participants without an unplanned hospital stay(up to 6 month)
- Number of atrial fibrillation (AF) recurrence(within 3 month after electrocardioversion)
- Time to first redo electrocardioversion(up to 6 month)
- Use of antiarrhythmic drugs(within 6 month after electrocardioversion)