Impact of Colchicine on Peri-Operative Major Adverse Cardiovascular Events in Patients With Prior Coronary Revascularization: The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial (POPCORN)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Non-cardiac surgery, Colchicine, Inflammation, Major adverse cardiovascular events
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Glomerular filtration rate <30mL/minute or on dialysis History of cirrhosis, chronic active hepatitis or severe hepatic disease History of myelodysplasia with current evidence of cytopenia 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) Undergoing immunosuppressive or immunostimulatory chemo or biologic therapy Pregnant (as confirmed by urine or serum test), nursing, or planning to become pregnant during study participation Participating in a competing study or unable to consent Any significant condition or situation that may put the participant at higher risk, confound the study results, or interfere with adherence to study procedures 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
Sites / Locations
- VA Long Beach Healthcare System, Long Beach, CARecruiting
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYRecruiting
- Durham VA Medical Center, Durham, NC
- Louis Stokes VA Medical Center, Cleveland, OH
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Colchicine
Placebo
One day before surgery: Colchicine 1.2 mg with 0.6 mg PO one hour later. This load will be followed by colchicine 0.6 mg twice daily for a total of 14 days.
Matching placebo at same time points as active comparator