NCT05459974

Use of Colchicine to Decrease Atrial Fibrillation Recurrence After Ablation

Status unknown Phase 3 Last updated 15 July 2022

What this trial tests

Phase 3 trial testing Colchicine 0.6 mg in Atrial Fibrillation in 224 participants. Status unknown.

Timeline

20 June 2022

Primary endpoint
30 November 2023

30 November 2024

Quick facts

Lead sponsor	Stony Brook University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	224
Start date	20 June 2022
Primary completion	30 November 2023
Estimated completion	30 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Colchicine 0.6 mg — full drug profile →
• Placebo

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Stony Brook University

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Therapeutics and Upcoming Clinical Trials Targeting Inflammation in Cardiovascular Diseases.
   Potere N, Bonaventura A, Abbate A. · · 2024 · cited 48× · PMID 39387118 · DOI 10.1161/atvbaha.124.319980
2. The Effect of Colchicine on Atrial Fibrillation: A Systematic Review and Meta-Analysis.
   Kommu S, Arepally S. · · 2023 · cited 17× · PMID 36819949 · DOI 10.7759/cureus.35120
3. Genetically predicted inflammatory proteins and the risk of atrial fibrillation: a bidirectional Mendelian randomization study.
   Ma Z, Chen Q, Liu Z, Li X, et al · · 2024 · cited 5× · PMID 38988665 · DOI 10.3389/fcvm.2024.1375750
4. Unmasking the Hidden Burden: Inflammation and Cardiovascular Disease <i>JAHA</i> Spotlight on the Role of the Immune System in Cardiovascular Health and Disease.
   Bartoli-Leonard F, Clark DE, Singhal NS, Nguyen PK. · · 2026 · cited 1× · PMID 41294082 · DOI 10.1161/jaha.125.047298
5. Tic-Tac: A Translational Approach in Mechanisms Associated with Irregular Heartbeat and Sinus Rhythm Restoration in Atrial Fibrillation Patients.
   Parra-Lucares A, Villa E, Romero-Hernández E, Méndez-Valdés G, et al · · 2023 · PMID 37629037 · DOI 10.3390/ijms241612859