NCT05928728

The COLchicine and Atrial FIBrillation Trial

The Colchicine and Atrial Fibrillation Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.

Detailed description

The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine 0.5 mg once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2023-07-03
• Primary completion: 2026-06-14
• Completion: 2028-11-01
• First posted: 2023-07-03
• Last updated: 2024-02-28

Locations

1 site across 1 country: Denmark