COlchicine for the preVention of postopErative atrial fibRillation in patients undergoing Coronary Artery By-pass Grafting

A randomized double blind controlled study to determine whether the use of colchicine is effective in reducing the incidence of atrial fibrillation after coronary artery by-pass grafting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72835417

Enrollment

320

Registered

2013-07-10

Start date

2013-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease ? Coronary Artery Surgery ? Atrial Fibrillation Circulatory System Atherosclerotic heart disease

Interventions

Patients will be randomized to receive placebo or colchicine, in addition to standard therapy, using a computer generated table of casual numbers. A separate randomization will be followed for patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All the patients electively submitted to coronary artery by-pass grafting with arterial conduits and without contraindications to colchicine

Exclusion criteria

Exclusion criteria: 1. Patients with preoperative atrial fibrillation 2. Known contraindication to Colchicine 3. Transaminases on admission more that 1.5 times the normal values 4. Creatinine clearance less than 30 ml/min 5. History of myopathy or elevated creatinine kinase 6. Hematologic disease 7. Gastrointestinal disease 8. Presence of systemic inflammatory or autoimmune disease

Design outcomes

Primary

Measure	Time frame
Postoperative Atrial Fibrillation as defined by the 2010 ESC Guideline for the treatment of Atrial Fibrillation occurring at any time during the postoperative period . The arrhythmia may be detected by any of the following postoperative exams a) ECG monitoring in the ICU; b) 48 hrs Holter ECG thereafter ; c) 12 Leads ECG twice a day until hospital discharge	—

Secondary

Measure	Time frame
Occurrence of any atrial arrhythmia Occurrence of any arrhythmia necessitating drug suspension Occurrence of any complication or major side effect of Colchicine	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026