Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Phase 3

Completed

Brief Summary: This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Detailed Description: Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
Known severe liver disease or current transaminases >1.5 times the upper normal limit
Current serum creatinine >2.5 mg/dl
Known myopathy or elevated baseline preoperative creatine kinase
Known blood dyscrasias
Significant gastrointestinal disease
Pregnant and lactating women
Known hypersensitivity to colchicine
Current treatment with colchicine for any indications
Emergency surgery

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose.

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Colchicine Side Effects	From date of randomization until the date of discharge, assessed up to 2 weeks	The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.
The Number of Participants With Atrial Fibrillation	From date of randomization until the date of discharge, assessed up to 2 weeks	The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant

Secondary Outcome Measures