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The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
NCT05618353 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG Colchicine
Study Locations (9)
New York
- VA Western New York Healthcare System, Buffalo, NY — Buffalo
- VA NY Harbor Healthcare System, New York, NY — New York
Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston
Alabama
- Birmingham VA Medical Center, Birmingham, AL — Birmingham
California
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
North Carolina
- Durham VA Medical Center, Durham, NC — Durham
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2023-08-21 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05618353
The ClinicalTrials.gov registry entry for NCT05618353 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05618353 reports 9 study locations spanning 7 distinct geographic areas — top geographies include New York, Texas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05618353 about?
NCT05618353 is a clinical study titled "The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial". 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 pr...
What is the current status of trial NCT05618353?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 700 participants. The study started on 2023-08-21. Estimated completion is 2029-04-30.
What conditions does trial NCT05618353 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05618353?
The interventions under investigation include: Placebo (DRUG), Colchicine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05618353?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05618353 being conducted?
This trial has 9 study locations across Alabama, California, Florida, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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