The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial

Prior treatment

• Undergoing immunosuppressive or immunostimulatory chemo or biologic therapy
• Patients on strong CYP3A4 and/or P-glycoprotein inhibitors (e.g., ritonavir, clarithromycin, diltiazem, verapamil) at baseline will also be excluded due to potential drug interactions
  • However, if one of these medications are started during the post-operative study period, dose adjustments will be made per drug package insert
  • Participants will also be instructed not to drink grapefruit juice while on study drug

Other illness

• Colchicine use within one month or history of colchicine intolerance
• Inflammatory bowel disease with history of diarrhea as presentation or chronic diarrhea
• Pre-existent progressive neuromuscular disease
  • amyotrophic lateral sclerosis
  • hereditary muscular disorders
  • myositis
  • necrotizing myopathy
  • myasthenia gravis
  • lambert-eaton syndrome
• History of cirrhosis, chronic active hepatitis or severe hepatic disease
• History of myelodysplasia with current evidence of cytopenia
• Any significant condition or situation that may put the participant at higher risk, confound the study results, or interfere with adherence to study procedures

Lab values

• Active infection defined as fever \>100.4oF or antibiotic use with white blood cell count greater than the upper limit of normal or lower than the lower limit of normal within 24 hours of randomization (major confounder with increased inflammatory markers)
• Pregnant (as confirmed by urine or serum test), nursing, or planning to become pregnant during study participation

Other

• Glomerular filtration rate \<30mL/minute or on dialysis
• Participating in a competing study or unable to consent

• Men and women with
• Prior coronary revascularization (via PCI or coronary artery bypass graft surgery) or high coronary atherosclerotic burden (\>70% let main disease or \>80% disease in the proximal or mid LAD, prox Cx, or prox or mid RCA on coronary angiography), AND
• Referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral vascular surgery, thoracic surgery).
• If planned for only a laparoscopic or endovascular approach (this includes a minimally invasive hybrid approach such as transcarotid artery revascularization), at least one component of the Revised Cardiac Risk Index score (history of myocardial infarction, history of congestive heart failure, history of transient ischemic attack or stroke, pre-operative use of insulin, pre-operative creatinine \>2 mg/dL) should be present.