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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Colchicine armActive Control1 Intervention

Group II: Placebo armPlacebo Group1 Intervention

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor

222 Previous Clinical Trials

41,704 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

~71 spots leftby Sep 2025

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