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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03310125.
Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery
(MINS) are among the most common serious complications occurring after thoracic surgery.
AF is the most common perioperative cardiac arrhythmia. The incidence of perioperative AF
in patients undergoing major thoracic surgery ranges from 10% in low-risk patients to as
high as 20% in high-risk patients. The course of patients with perioperative AF is
frequently complicated by hemodynamic instability, problems with managing anticoagulation
in the early postoperative period, prolonged intensive care unit and hospital stays, and
increased costs. Patients who develop perioperative AF (POAF) or MINS also have a
significantly increased risk of death and stroke.
Colchicine is an inexpensive drug and a highly effective anti-inflammatory agent that
holds great potential for preventing POAF and MINS in patients undergoing thoracic
surgery. Data from cardiac surgery patients suggest that prevention of POAF using
colchicine is feasible, but whether this concept is also applicable to patients
undergoing thoracic surgery, where the risk of POAF is lower and underlying mechanisms
may be different, is currently unclear. The 'Colchicine for the prevention of
perioperative AF' (COP-AF) trial has been designed as a large randomized, double blind,
placebo controlled trial to determine whether colchicine, a potent, safe and inexpensive
anti-inflammatory drug, lowers the risk of perioperative AF, MINS, and other inflammatory
complications in patients undergoing thoracic surgery. The primary objective of this
trial is to determine whether a 10-day course of colchicine 0.5mg twice daily reduces the
incidence of perioperative AF and MINS within 14 days after thoracic surgery.
Lead OrganizationPopulation Health Research Institute