Clinical trial NCT05890664: Colchicine After Electrocardioversion for Atrial Fibrillation
Official title: Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atrial Fibrillation
Cardiac Arrhythmia
Keywords: Electrocardioversion
Colchicine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Heart Foundation
name: Fondation Machaon, Switzerland, Genf
name: Foundation for Cardiovascular Research Basel
First posted: 2023-06-06
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, placebo-controlled trial.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Age \&gt;18 years
* ECG-documented AF prior to ECV
* Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥30 minutes after ECV
* Ability to give written informed consent

Exclusion Criteria:

* AF persistence after cardioversion or early AF recurrence within 30 minutes 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\&lt; 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 \&lt;1 year

Primary outcomes:
measure: Number of atrial fibrillation (AF) recurrence
timeFrame: within 6 month after electrocardioversion
Secondary outcomes:
measure: Number of atrial fibrillation (AF) recurrence
timeFrame: within 1 month after electrocardioversion
measure: Number of atrial fibrillation (AF) recurrence
timeFrame: within 3 month after electrocardioversion
measure: Time to first redo electrocardioversion
timeFrame: up to 6 month
measure: Use of antiarrhythmic drugs
timeFrame: within 6 month after electrocardioversion
measure: Number of survived participants without an unplanned hospital stay
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Cantonal Hospital Baselland (KSBL)
state: Baselland
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
city: Luzern
country: Switzerland
facility: Lucerne Cantonal Hospital
city: Olten
country: Switzerland
facility: Cantonal Hospital Olten
city: Rheinfelden
country: Switzerland
facility: Herzpraxis am Rhein
city: Solothurn
country: Switzerland
facility: Solothurner Spitäler AG
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Philipp Krisai, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: