NCT05618353 · VA Office of Research and Development
The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
(POPCORN)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Colchicine
0.6 mg tablets
DRUG
Placebo
Matching placebo
Primary outcome measures
Major adverse cardiovascular events
Time frame: 30 days post-operation
Defined as a composite rate of myocardial injury, non-fatal MI, non-fatal stroke, and all-cause mortality.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Birmingham, Alabama
- Long Beach, California
- Gainesville, Florida
- Buffalo, New York
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
- Dallas, Texas
- Houston, Texas
Collaborators
NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations