Colchicine arm for Atrial Fibrillation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stony Brook University Hospital, Stony Brook, NY
Atrial Fibrillation+1 More
Colchicine 0.6 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Ablation of atrial fibrillation (AFib) has been recommended as a therapeutic option when rhythm maintenance strategy is sought. One of the main objectives of an AFib ablation procedure is electrical isolation of the pulmonary veins, which have been identified as common triggering sites of the arrhythmia. The pathophysiology of AFib is not fully elucidated. Inflammation seems to play an important role in the initiation and maintenance of AFib. Previous studies have shown that inflammatory markers reactivity (eg, C-reactive protein [CRP] complex levels, elevation of white blood cells) are increased in patients who develop AFib. Similarly, recurrence of AFib within the first few weeks after ablation procedure seems to be mediated by an inflammatory process triggered by the ablation per se as implied by increased early CRP levels in AFib ablation patients. On the other hand, AFib can further induce and maintain a cascade of inflammatory events leading to electrical and structural atrial remodeling which leads to higher incidence of Afib development. Many trials have investigated the role of anti-inflammatory agents in preventing post-ablation AFib, using various treatment regimens such as corticosteroid therapy, antiarrhythmic medications like amiodarone, intravenous magnesium, atorvastatin, and colchicine. 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. There is limited knowledge regarding the impact of colchicine duration and dosing on post-ablation Afib recurrence and the self-perceived quality of life. The information obtained from this study will ultimately guide future clinical practice to ensure safer outcomes.

Eligible Conditions

  • Atrial Fibrillation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Atrial Fibrillation

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 12 months

1 month
Compliance of medication use
Pericarditis outcomes
Safety and Tolerability of Colchicine
12 months
All-cause mortality outcomes
Atrial fibrillation burden
Atrial fibrillation recurrence (Efficacy)
Procedure related outcomes
at 1 month
Post-ablation quality of life

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Atrial Fibrillation

Trial Design

2 Treatment Groups

Colchicine arm
1 of 2
Placebo arm
1 of 2
Active Control
Non-Treatment Group

224 Total Participants · 2 Treatment Groups

Primary Treatment: Colchicine arm · Has Placebo Group · Phase 3

Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Colchicine arm
Drug
ActiveComparator Group · 1 Intervention: Colchicine 0.6 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Stony Brook University Hospital · Stony Brook, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2004First Recorded Clinical Trial
5 TrialsResearching Atrial Fibrillation
77 CompletedClinical Trials

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
193 Previous Clinical Trials
34,363 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
13 Patients Enrolled for Atrial Fibrillation
Abhijeet Singh, MDPrincipal Investigatorabhijeet.singh@stonybrookmedicine.edu

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.