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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive adult patients undergoing elective cardiac surgery 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colchicine<br>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. | Drug: Colchicine<br>* colchicine given as per trial protocol<br>|
| No Intervention: No colchicine<br>In this arm no active medication was administered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Atrial Fibrillation | The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant | From date of randomization until the date of discharge, assessed up to 2 weeks | 
| The Number of Participants With Colchicine Side Effects | 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. | From date of randomization until the date of discharge, assessed up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Colchicine, Cardiac surgery