Actively Recruiting
The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
Led by VA Office of Research and Development · Updated on 2026-04-22
700
Participants Needed
9
Research Sites
297 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
N
NYU Langone Health
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women with prior coronary revascularization (PCI or coronary artery bypass graft) or high coronary atherosclerotic burden (>70% left main disease or >80% disease in specific coronary arteries)
- Referred for intermediate- or high-risk surgery such as general abdominal, intraperitoneal, neurosurgery, suprainguinal, peripheral vascular, or thoracic surgery
- For planned laparoscopic or endovascular surgery, at least one Revised Cardiac Risk Index factor must be present (history of myocardial infarction, congestive heart failure, transient ischemic attack or stroke, pre-operative insulin use, or elevated creatinine >2 mg/dL)
You will not qualify if you...
- Use of colchicine within one month or history of colchicine intolerance
- Inflammatory bowel disease with diarrhea symptoms
- Progressive neuromuscular diseases including amyotrophic lateral sclerosis, hereditary muscular disorders, myositis, necrotizing myopathy, myasthenia gravis, or Lambert-Eaton syndrome
- Glomerular filtration rate below 30 mL/minute or dialysis treatment
- History of cirrhosis, chronic active hepatitis, or severe liver disease
- History of myelodysplasia with current cytopenia
- Active infection defined by fever over 100.4°F or abnormal white blood cell count within 24 hours of randomization
- Undergoing immunosuppressive or immunostimulatory chemotherapy or biologic therapy
- Pregnant, nursing, or planning pregnancy during the study
- Participation in another competing study or inability to consent
- Any significant condition increasing risk, confounding results, or interfering with study adherence
- Use of strong CYP3A4 and/or P-glycoprotein inhibitors at baseline (e.g., ritonavir, clarithromycin, diltiazem, verapamil) unless adjustments are made during the study; grapefruit juice use is prohibited while on study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233-1927
Actively Recruiting
2
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
3
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
4
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215-1129
Actively Recruiting
5
VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011
Actively Recruiting
6
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
7
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
8
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
9
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
Research Team
J
Jennifer Yudkevich
CONTACT
T
Taj Kaur
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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