Colchicine After Electrocardioversion for Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial

Conditions
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Atrial Fibrillation, Cardiac Arrhythmia

Intervention / Treatment
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* Drug: Colchicine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double-blind, placebo-controlled trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Drug: Colchicine<br>* Colchicine 0.5 mg (oral) once daily for 90 days. The chemical name for colchicine is (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. Colchicine consists of pale yellow scales or powder. It is soluble in water, freely soluble in alcohol, and slightly soluble in ether.<br>|
| Placebo Comparator: Control Group<br>Study participants in the placebo group will receive a matched placebo. | Drug: Placebo<br>* Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of atrial fibrillation (AF) recurrence | 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. | within 6 month after electrocardioversion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of atrial fibrillation (AF) recurrence | The secondary outcome of AF recurrence within 1 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. | within 1 month after electrocardioversion | 
| Number of atrial fibrillation (AF) recurrence | The secondary outcome of AF recurrence within 3 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. | within 3 month after electrocardioversion | 
| Time to first redo electrocardioversion | Time to first redo electrocardioversion | up to 6 month | 
| Use of antiarrhythmic drugs | Assessment of medication intake by study staff Vaughan-Williams classification class 1 and 3 of antiarrhythmic drugs will be documented (1 = sodium channel blockade, 3 = potassium channel blockade) | within 6 month after electrocardioversion | 
| Number of survived participants without an unplanned hosptial stay | Number of survived participants without an unplanned hosptial stay | up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrocardioversion, Colchicine