Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (45% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 7 distinct geographic areas - top geographies include 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.
-
Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI
RECRUITING · Phase 4
-
Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
RECRUITING · Phase 4
-
Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
RECRUITING · Phase 4
-
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
RECRUITING · Phase 4
-
Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors
RECRUITING · Phase 4
-
Etomidate Versus Propofol in CABG Surgery
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.