Overview
Colchicine After Electrocardioversion for Atrial Fibrillation
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-12-01
2025-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, Basel, SwitzerlandCollaborators:
Fondation Machaon, Switzerland, Genf
Foundation for Cardiovascular Research Basel
Swiss Heart FoundationTreatments:
Colchicine
Criteria
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