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NCT04906720: PAPERS

Post-Ablation Pericarditis Reduction Study

Completed Phase 2 Last updated 8 November 2022
What this trial tests

Phase 2 trial testing Colchicine in Atrial Fibrillation in 248 participants. Completed in 1 October 2022.

Timeline
20 May 2021
Primary endpoint
30 January 2022
1 October 2022

Quick facts

Lead sponsorSt. Vincent Cardiovascular Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment248
Start date20 May 2021
Primary completion30 January 2022
Estimated completion1 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

St. Vincent Cardiovascular Research Institute

Who can join

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

Sponsor's own description

There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to 1. Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating). 2. Identify potential differences in patients undergoing PVI only versus PVI + additional ablation 3. Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without 4. Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF

Publications & conference data

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

  1. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review.
    Zhang FS, He QZ, Qin CH, Little PJ, et al · · 2022 · cited 98× · PMID 35046517 · DOI 10.1038/s41401-021-00835-w
  2. Emerging Antiarrhythmic Drugs for Atrial Fibrillation.
    Saljic A, Heijman J, Dobrev D. · · 2022 · cited 38× · PMID 35456912 · DOI 10.3390/ijms23084096

Verify or expand the search:

Other trials of Colchicine

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other St. Vincent Cardiovascular Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04906720.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing