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NCT05618353 · ClinicalTrials.gov registry record · Phase 4
The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
A Phase 4 study of Coronary Artery Disease, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 700
- Enrollment target
- 9
- Study locations
NCT05618353: Recruiting Phase 4 study of Coronary Artery Disease, sponsored by VA Office of Research and Development.
NCT05618353 is a Phase 4 study of Coronary Artery Disease that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 700 participants, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (45% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05618353, a Phase 4 study of Coronary Artery Disease, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 700 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Defined as a composite rate of myocardial injury, non-fatal MI, non-fatal stroke, and all-cause mortality.
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 |
What NCT05618353 shows while recruiting
NCT05618353 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (45% lower).
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.
NCT05618353 lists 9 locations in 7 states (New York, Texas, Alabama).
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.
What interventions are being tested in trial NCT05618353?
The interventions under investigation include: Placebo (DRUG), Colchicine (DRUG).
Who is sponsoring clinical trial NCT05618353?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05618353's enrollment target sits among peer trials
700 61st of 219 higher than 158 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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