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RECRUITING
NCT05618353
PHASE4

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Impact of Colchicine on Peri-Operative Major Adverse Cardiovascular Events in Patients With Prior Coronary Revascularization

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2023-08-21

Completion Date

2029-04-30

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

Colchicine

0.6 mg tablets

DRUG

Placebo

Matching placebo

Locations (9)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

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

Gainesville, Florida, United States

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

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

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States