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Colchicine for Atrial Fibrillation Recurrence After Ablation

Phase 3
Recruiting
Led By Abhijeet Singh, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with paroxysmal or persistent atrial fibrillation scheduled to undergo index or repeat Afib ablation procedure (radiofrequency) and or cavotricuspid line ablation, other right/left atrial sites, left at discretion of treating physician.
Age ≥ 18 years
Must not have
Clinically overt hepatic disease
Serious gastrointestinal disease (severe gastritis or diarrhea)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial

Summary

This trial is investigating the role of colchicine in preventing atrial fibrillation (Afib) after an ablation procedure. Previous studies have shown that colchicine can lead to decreased recurrence of post-ablation Afib with a beneficial impact in self-perceived quality of life of the patients.

Who is the study for?
This trial is for adults over 18 who can consent and are scheduled for atrial fibrillation ablation. It's not for pregnant or breastfeeding women, those with severe kidney disease, serious blood disorders, significant liver disease, or a history of bad reactions to colchicine/amiodarone/dronedarone.
What is being tested?
The study tests if Colchicine (0.6 mg) reduces the recurrence of atrial fibrillation after an ablation procedure compared to a placebo. The goal is to see how well it works and its effect on patients' quality of life.
What are the potential side effects?
Colchicine may cause gastrointestinal issues like diarrhea or nausea and could potentially lead to muscle pain or weakness. People with allergies or certain health conditions were excluded due to higher risk of side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a procedure to treat irregular heartbeats.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a known liver condition.
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I have severe stomach issues or diarrhea.
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I am not taking medications like clarithromycin or ketoconazole that would interfere with colchicine or amiodarone.
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I am not pregnant, breastfeeding, and I use effective birth control.
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I am scheduled for a procedure to treat irregular heartbeats not involving the pulmonary veins.
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My kidney function is severely reduced.
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I have a serious blood disorder.
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I am currently taking or need to take colchicine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Atrial Fibrillation
Post-ablation quality of life
Secondary study objectives
All-cause mortality outcomes
Atrial fibrillation burden
Compliance of medication use
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Colchicine armActive Control1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
222 Previous Clinical Trials
41,807 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
13 Patients Enrolled for Atrial Fibrillation
Abhijeet Singh, MDPrincipal Investigatorabhijeet.singh@stonybrookmedicine.edu

Media Library

Colchicine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05459974 — Phase 3
Atrial Fibrillation Research Study Groups: Colchicine arm, Placebo arm
Atrial Fibrillation Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT05459974 — Phase 3
Colchicine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459974 — Phase 3
~66 spots leftby Nov 2025
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