Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The prevention of perioperative atrial fibrillation has the potential to reduce mortality, stroke, and hospital stays in patients undergoing thoracic surgery. Data from cardiac surgery patients suggest that prevention of perioperative atrial fibrillation using an anti-inflammatory agent, such as colchicine, is feasible. The COP-AF trial will assess whether the administration of oral colchicine will reduce the incidence of perioperative atrial fibrillation in patients undergoing major thoracic surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborators: Hamilton Health Sciences Corporation; McMaster University
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• all patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are ≥55 years of age and in sinus rhythm at the time of randomization.

Exclusion Criteria:

• patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);

• patients with contraindications to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m);

• patients not expected to take oral medications for >24 hours after surgery (e.g., esophagectomy);

• patients scheduled for lung transplantation;

• patients taking non-study colchicine before surgery;

• patients scheduled to take clarithromycin, cyclosporine, ketoconazole, or itraconazole during the first 10 days after surgery;

• HIV patients treated with antiretroviral therapy.