Recruiting
Phase 3

Colchicine

Sponsor:

Stony Brook University

Code:

NCT05459974

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colchicine 0.6 mg

Placebo

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT05459974

Start date

Jun 20, 2022

Status verified date

Jul, 2022

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years
2. 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.
3. Ability of patient to provide informed consent

Exclusion Criteria:

1. Patients scheduled for ablation of atrial tachycardia/flutter without planned pulmonary vein isolation (i.e. without pulmonary vein isolation).
2. Known hypersensitivity to colchicine/amiodarone/dronedarone
3. Absolute indication for or ongoing treatment with colchicine
4. Clinically overt hepatic disease
5. Serious gastrointestinal disease (severe gastritis or diarrhea)
6. Severe renal disease (eGFR< 30ml/min/1.73m2)
7. Clinically significant blood dyscrasia (e.g., myelodysplasia)
8. Patients already on a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole), precluding the administration of colchicine or amiodarone/dronedarone.
9. Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Colchicine arm

placebo comparator: Placebo arm

Interventions

Colchicine 0.6 mg

Colchicine 0.6 mg once daily for 30 days after the atrial fibrillation ablation

Placebo

Placebo pill once daily for 30 days after the atrial fibrillation ablation

Primary outcome measure

  • Atrial fibrillation recurrence (Efficacy) [ Time Frame: 12 months ]
  • Post-ablation quality of life [ Time Frame: at 12 months ]
  • Post-ablation quality of life [ Time Frame: at 1 month ]

Central Contacts and Locations

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

More Information

Sponsor

Stony Brook University

Last update posted

Jul 15, 2022

Last verified

Jul, 2022

Keywords

  • Atrial fibrillation
  • Ablation outcomes
  • Atrial fibrillation recurrence
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2022-07-15.