Colchicine After Electrocardioversion for Atrial Fibrillation
Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
University Hospital, Basel, Switzerland
416 participants
Apr 14, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria13
- 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
Interventions
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.
Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05890664