Colchicine After Electrocardioversion for Atrial Fibrillation
Recruiting · NCT05890664 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
ColchicinePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \>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\< 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
Where it is running
8 locations listed.
- University Hospital Basel - Basel, Switzerland
- University Hospital Bern - Bern, Switzerland
- Lausanne University Hospital - Lausanne, Switzerland
- Lucerne Cantonal Hospital - Lucerne, Switzerland
- Cantonal Hospital Olten - Olten, Switzerland
- Herzpraxis am Rhein - Rheinfelden, Switzerland
- Solothurner Spitäler AG - Solothurn, Switzerland
- Cantonal Hospital Baselland (KSBL) - Bruderholz, Basel-Landschaft, Switzerland