Using Colchicine to Prevent Atrial Fibrillation Recurrence After Heart Rhythm Restoration
Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
This study is testing if a low-dose Colchicine treatment can help prevent Atrial Fibrillation from coming back in people who have just had their heart rhythm restored.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 8 sites (Bruderholz, Basel-Landschaft and 7 other locations) |
| Trial ID | NCT05890664 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a 3-month low-dose Colchicine treatment in reducing the recurrence of Atrial Fibrillation (AF) following electrocardioversion (ECV). Atrial fibrillation is a prevalent cardiac arrhythmia that poses significant health risks, and current treatment options are insufficient as about 60% of patients experience a short-term recurrence after ECV. The researchers aim to explore the role of inflammation in AF and how targeting it with Colchicine may improve patient outcomes. The study will compare the effects of Colchicine against a placebo in eligible patients who have successfully converted to sinus rhythm after ECV.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have documented Atrial Fibrillation and have successfully converted to sinus rhythm after electrocardioversion.
Not a fit: Patients who experience persistent Atrial Fibrillation after cardioversion or have contraindications to Colchicine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of Atrial Fibrillation, improving long-term heart health for patients.
How similar studies have performed: While the approach of targeting inflammation in Atrial Fibrillation is gaining interest, this specific application of Colchicine post-ECV is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 ≥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
Where this trial is running
Bruderholz, Basel-Landschaft and 7 other locations
- Cantonal Hospital Baselland (KSBL) — Bruderholz, Basel-Landschaft, Switzerland (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- University Hospital Bern — Bern, Switzerland (Recruiting)
- Lausanne University Hospital — Lausanne, Switzerland (Recruiting)
- Lucerne Cantonal Hospital — Lucerne, Switzerland (Recruiting)
- Cantonal Hospital Olten — Olten, Switzerland (Recruiting)
- Herzpraxis am Rhein — Rheinfelden, Switzerland (Recruiting)
- Solothurner Spitäler AG — Solothurn, Switzerland (Recruiting)
Study contacts
- Principal investigator: Philipp Krisai, PD Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Philipp Krisai, PD Dr. med.
- Email: Philipp.krisai@usb.ch
- Phone: +41 61 265 25 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.