Overview

Colchicine After Electrocardioversion for Atrial Fibrillation

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborators:
Fondation Machaon, Switzerland, Genf
Foundation for Cardiovascular Research Basel
Swiss Heart Foundation
Treatments:
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