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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Atrial Fibrillation
Post-ablation quality of life
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
215 Previous Clinical Trials
39,703 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with the Colchicine arm of this trial?

"Colchicine arm is estimated to be a 3 on the Power team's safety scale. This is due to Phase 3 trial data, meaning that there is both efficacy and multiple rounds of safety data supporting use of the medication."

Answered by AI

Are there any current vacancies for people interested in participating in this clinical trial?

"It seems that this particular clinical trial is still enrolling patients, as the last update on clinicaltrials.gov was on 7/11/2022. The trial was initially posted 6/20/2022."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Stony Brook University Hospital
~79 spots leftby Apr 2025