Recruiting

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

Sponsor:

VA Office of Research and Development

Code:

NCT05618353

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colchicine

Placebo

Study Details

Brief summary:

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

Coronary Artery Disease

Study ID

NCT05618353

Start date

Aug 21, 2023

Status verified date

Apr, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Colchicine

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.

placebo comparator: Placebo

Matching placebo at same time points as active comparator

Interventions

Colchicine

0.6 mg tablets

Placebo

Matching placebo

Primary outcome measure

Major adverse cardiovascular events [ Time Frame: 30 days post-operation ]

Central Contacts and Locations

Central contacts

Jennifer Yudkevich

(718) 836-6600 jennifer.yudkevich@va.gov

Taj Kaur

(212) 686-7500 tajinder.kaur@va.gov

Locations

Birmingham VA Medical Center, Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233-1927

Contacts

Fadi Hage, MD

fadi.hage@va.gov

Patti Smith

patti.smith2@va.gov

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Arnold Seto, MD

arnold.seto@va.gov

Christine Ma

christine.agas@va.gov

North Florida/South Georgia Veterans Health System, Gainesville, FL

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Scott Berceli, MD

scott.berceli@va.gov

Joanne Angle

joanne.angle@va.gov

VA Western New York Healthcare System, Buffalo, NY

Recruiting

Buffalo, New York, United States, 14215-1129

Contacts

Mariel Rivero

mariel.rivero@va.gov

Ann Galla

ann.galla@va.gov

VA NY Harbor Healthcare System, New York, NY

Recruiting

New York, New York, United States, 10010-5011

Contacts

Jennifer Yudkevich

718-836-6600 jennifer.yudkevich@va.gov

Taj Kaur

(212) 686-7500 tajinder.kaur@va.gov

Principal Investigator:

Binita Shah, MD

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Rajesh Swaminathan, MD

rajesh.swaminathan@va.gov

Kathy Aristy

kathy.aristy@va.gov

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

David Zidar, MD

david.zidar@va.gov

Tai-Lyn Wilkerson

tai-lyn.wilkerson@va.gov

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Shirling Tsai, MD

shirling.tsai@va.gov

Anthony Emerick

anthony.emerick@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Neal Barshes, MD

neal.barshes@va.gov

Ezinne Achebe

ezinne.achebe@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

Coronary artery disease
Non-cardiac surgery
Colchicine
Inflammation
Major adverse cardiovascular events

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-22.