Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoraci… (NCT03310125) | Clinical Trial Compass
CompletedPhase 3
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
United States3,209 participantsStarted 2018-02-14
Plain-language summary
The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major 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 and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. are undergoing thoracic surgery with general anesthesia;
✓. are greater than or equal to 55 years of age at the time of randomization;
✓. are expected to require at least an overnight hospital admission after surgery; and
✓. provide written informed consent to participate.
Exclusion criteria
✕. have a prior history of documented atrial fibrillation;
✕. are currently taking anti-arrhythmic medication other than β-blockers, calcium channels blockers or digoxin;
✕. are undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies);
✕. have a contraindication to colchicine (i.e., allergy to colchicine, myelodysplastic disorders, or an estimated glomerular filtration rate less than 30 mL/min/1.73m);
✕. are not expected to take oral medications for greater than 24 hours after surgery (e.g., esophagectomy);
What they're measuring
1
Clinically important perioperative atrial fibrillation/atrial flutter