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New treatment option for Atrial Fibrillation
Official title Colchicine After Electrocardioversion for Atrial Fibrillation
ClinicalTrials.gov ID: NCT05890664
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bruderholz, Basel-Landschaft, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Lausanne, Switzerland
- Lucerne, Switzerland
- Olten, Switzerland
- Rheinfelden, Switzerland
- Solothurn, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruderholz, Basel-Landschaft, Switzerland; Basel, Switzerland; Bern, Switzerland; Lausanne, Switzerland; Lucerne, Switzerland; Olten, Switzerland and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.