Colchicine After Electrocardioversion for Atrial Fibrillation
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Atrial Fibrillation, Cardiac Arrhythmia
In brief
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.
Key facts
- Study ID
- NCT05890664
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 416
- Starts
- 2024-04-14
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Cantonal Hospital Baselland (KSBL) — Bruderholz, Basel-Landschaft, Switzerland (enrolling)
- University Hospital Basel — Basel, Switzerland (enrolling)
- University Hospital Bern — Bern, Switzerland (enrolling)
- Lausanne University Hospital — Lausanne, Switzerland (enrolling)
- Lucerne Cantonal Hospital — Lucerne, Switzerland (enrolling)
- Cantonal Hospital Olten — Olten, Switzerland (enrolling)
- Herzpraxis am Rhein — Rheinfelden, Switzerland (enrolling)
- Solothurner Spitäler AG — Solothurn, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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