The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Coronary Artery Disease
In brief
Heart disease remains the leading cause of death in Veterans. Inflammation in the arteries of the heart may increase the risk of cardiac death. Patients with heart disease undergoing major surgery are at increased risk of complications after surgery, including heart attack, stroke, and death. The proposed research seeks to better understand the role of inflammation in the damage to the heart and blood vessels after major surgery. This research also seeks to identify the potential beneficial role of a safe medication, colchicine, which has direct effects on inflammatory cells and has been used in the treatment of inflammatory diseases for more than 2000 years, on reducing the rate of complications after surgery. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of heart injury, stroke, or death after major surgery.
Key facts
- Study ID
- NCT05618353
- Run by
- VA Office of Research and Development
- People needed
- 700
- Starts
- 2023-08-21
- Expected to finish
- 2029-04-30
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (enrolling)
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)
- VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States (enrolling)
- VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (enrolling)
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (enrolling)
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (enrolling)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.