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

NCT05618353 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

DRUG

Colchicine

0.6 mg tablets

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2028-07-31
Completion
2029-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05618353 on ClinicalTrials.gov