Actively Recruiting
Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-28
416
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Atrial fibrillation is the most common heart rhythm problem worldwide and increases the risk of heart failure, stroke, and death. Researchers expect its prevalence to rise, especially in people over 65 years old, with about one in three developing atrial fibrillation. Electrocardioversion is a procedure that restores normal heart rhythm but often results in the arrhythmia returning within a short time. This trial aims to study whether inflammation plays a role in this recurrence and if treating it can reduce the return of atrial fibrillation after electrocardioversion. The trial compares two groups: one receives a daily oral dose of 0.5 mg Colchicine for three months, taken in the morning without a loading dose, alongside their usual treatments. The other group receives a matched placebo. This is a randomized, triple-blind Phase 3 study evaluating the effect of low-dose Colchicine on preventing atrial fibrillation recurrence after electrocardioversion. Participants will be monitored for recurrence of atrial fibrillation over six months following electrocardioversion. Researchers will assess the number of arrhythmia recurrences at one, three, and six months, the time to any repeat electrocardioversion, use of antiarrhythmic drugs, and hospitalizations. Safety and overall wellbeing will also be followed during this period, with the main outcome focused on arrhythmia recurrence within six months.
CONDITIONS
Brief Title
Colchicine After Electrocardioversion for Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- ECG-confirmed atrial fibrillation before electrocardioversion
- Successful electrocardioversion with conversion to sinus rhythm lasting at least 30 minutes
- Ability to provide written informed consent
You will not qualify if you...
- Persistence of atrial fibrillation after cardioversion or early recurrence within 30 minutes
- Any heart rhythm other than atrial fibrillation before cardioversion
- Pulmonary vein isolation within 3 months before or planned within 3 months after electrocardioversion
- Known intolerance or allergy to Colchicine
- Any other medical reason requiring Colchicine
- Use of strong CYP3A4 or P-Glycoprotein inhibitors
- Serious gastrointestinal disease such as severe gastritis or diarrhea
- Clinically overt liver disease
- Severe kidney disease with eGFR less than 30 ml/min/1.73m2
- Significant blood disorders such as myelodysplasia
- Significant immune suppression like after transplantation or rheumatic disease
- Pregnant or breastfeeding women, or women of child-bearing potential not using highly effective birth control
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive a daily oral dose of Colchicine or placebo for 90 days following electrocardioversion to reduce the recurrence of atrial fibrillation.
Regular visits to monitor treatment and health status during the 3 months
Duration - Up to 6 months
Participants are monitored for recurrence of atrial fibrillation and other health outcomes up to 6 months after electrocardioversion.
Periodic visits during follow-up to assess heart rhythm and health status
Trial Site Locations
Total: 8 locations
1
Cantonal Hospital Baselland (KSBL)
Bruderholz, Basel-Landschaft, Switzerland, 4101
Actively Recruiting
2
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
University Hospital Bern
Bern, Switzerland, 3010
Actively Recruiting
4
Lausanne University Hospital
Lausanne, Switzerland, 1011
Actively Recruiting
5
Lucerne Cantonal Hospital
Lucerne, Switzerland, 6000
Actively Recruiting
6
Cantonal Hospital Olten
Olten, Switzerland, 4600
Actively Recruiting
7
Herzpraxis am Rhein
Rheinfelden, Switzerland, 4310
Actively Recruiting
8
Solothurner Spitäler AG
Solothurn, Switzerland, 4500
Actively Recruiting
Research Team
P
Philipp Krisai, PD Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here