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Colchicine After Electrocardioversion for Atrial Fibrillation
RECRUITINGPhase 3Sponsored by University Hospital, Basel, Switzerland
Actively Recruiting
PhasePhase 3
SponsorUniversity Hospital, Basel, Switzerland
Started2024-04-14
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05890664
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
Atrial FibrillationCardiac ArrhythmiaHeart Disease
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Actively Recruiting
PhasePhase 3
SponsorUniversity Hospital, Basel, Switzerland
Started2024-04-14
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05890664