A Phase 3 interventional study of Colchicine 0.6 mg and Matching placebo in Atrial Fibrillation and Recurrence, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Treatment
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation.
This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 202 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Drug: Colchicine 0.6 mg
Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Drug: Matching placebo
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Average monthly enrollment rate
Average number of patients enrolled per month
Time frame: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Compliance with study treatment
Number of provided capsules taken (measured as a proportion of 20 capsules)
Time frame: From randomization until 10 days after catheter ablation
Rate of complete follow-up at 6 months
This will describe the rate of patients for whom the 6-month follow visit can be completed
Time frame: From inception until completion of the study
Rate of non-infectious diarrhea
Three or more loose stools per day, in absence of an overt infectious cause
Time frame: From randomization until 10 days after catheter ablation
Rate of signs and symptoms of pericarditis
Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain
Time frame: From randomization until 10 days after catheter ablation
Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation
Any episode of atrial fibrillation lasting \> 30 seconds within 2 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition
Time frame: From randomization until 2 weeks after catheter ablation for atrial fibrillation
Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation
Any episode of atrial fibrillation lasting \> 30 seconds between 10-15 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition
Time frame: Between week 10 and 15 after catheter ablation for atrial fibrillation
Rate of patients with composite clinical endpoint
Emergency department visit: Patient seeking medical attention at any emergency department or Hospitalization for cardiovascular cause: Minimum of one overnight stay in hospital for cardiovascular reason (e.g. recurrence of atrial fibrillation, atrial flutter, atrial tachycardia; hypotension; hypertension; heart failure; myocardial infarction; bleeding, stroke etc.) or Cardioversion: Pharmacological or electrical attempt of or restoring sinus rhythm, irrespective of success of the procedure or Repeat ablation for atrial fibrillation, atrial flutter or left atrial tachycardia: Catheter-guided pulmonary vein isolation, or ablation of cavotricuspid isthmus, or ablation for other left atrial tachycardia (e.g. macro-reentrant tachycardia, focal tachycardia) after the index procedure
Time frame: Through study completion (estimated to be up to 24 months)
Rate of all-cause mortality
This will describe the rate of all-cause mortality during the course of the study.
Time frame: Through study completion (estimated to be up to 24 months)
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute