Title
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
Phase
Phase 3Lead Sponsor
Jordan Collaborating Cardiology GroupStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
ArrhythmiaIntervention/Treatment
colchicine ...Study Participants
360This 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
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.
colchicine given as per trial protocol
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.
In this arm no active medication was administered
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
| Event Type | Organ System | Event Term | Colchicine | No Colchicine |
|---|
The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
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.
