Back to search results

POPCORN Trial: Colchicine for Heart Disease Patients Undergoing Surgery

This study, called POPCORN, is looking at whether a medication called colchicine can help reduce heart-related problems in people with coronary artery disease (blocked heart arteries) who are having major surgery. Heart disease is a serious concern for Veterans, and inflammation in the arteries may increase risks. If you have a history of heart procedures (like stents or bypass surgery) or significant artery blockages, and are scheduled for certain intermediate- or high-risk surgeries, you might be eligible. Researchers want to see if colchicine, which has anti-inflammatory effects, can lower the chance of serious heart events like heart attack or stroke within 30 days after your operation. The study aims to enroll 700 participants.

Study design
This interventional study plans to enroll 700 participants. It compares colchicine (0.6 mg tablets) to a matching placebo (an inactive pill).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for major adverse cardiovascular events for 30 days after their operation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05618353

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
VA Office of Research and Development
~700 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:ColchicinePlacebo

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major adverse cardiovascular events
Measured over 30 days post-operation

Conditions

Coronary Artery Disease

Explore related trials

Coronary Artery Disease

Where it's being run

9 sites across 7 states
New York2
Texas2
Alabama1
California1
Florida1
North Carolina1
Ohio1

Study leadership

  • Binita Shah, MD · PRINCIPAL_INVESTIGATOR · VA NY Harbor Healthcare System, New York, NY

Who to contact

Jennifer Yudkevich
[email protected]
(718) 836-6600 · ext. 4719
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Major adverse cardiovascular events30 days post-operation

    Defined as a composite rate of myocardial injury, non-fatal MI, non-fatal stroke, and all-cause mortality.