RecruitingPhase 4NCT05618353

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

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


Sponsor

VA Office of Research and Development

Enrollment

700 participants

Start Date

Aug 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Colchicine and a drug called Placebo for people with coronary artery disease. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine

0.6 mg tablets

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT05618353


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