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New treatment option for Coronary Artery Disease
Official title The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial
ClinicalTrials.gov ID: NCT05618353
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for coronary artery disease.
Also referred to as Colcrys.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Heart disease remains the leading cause of death in Veterans. Inflammation in the arteries of the heart may increase the risk of cardiac death.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women with
- Prior coronary revascularization (via PCI or coronary artery bypass graft surgery) or high coronary atherosclerotic burden (\>70% let main disease or...
- Referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral...
- If planned for only a laparoscopic or endovascular approach (this includes a minimally invasive hybrid approach such as transcarotid artery...
You likely can't join if
- Colchicine use within one month or history of colchicine intolerance
- Inflammatory bowel disease with history of diarrhea as presentation or chronic diarrhea
- Pre-existent progressive neuromuscular disease
- amyotrophic lateral sclerosis
- hereditary muscular disorders
- myositis
See the full eligibility criteria
- Men and women with
- Prior coronary revascularization (via PCI or coronary artery bypass graft surgery) or high coronary atherosclerotic burden (\>70% let main disease or \>80% disease in the proximal or mid LAD, prox Cx, or prox or mid RCA...
- Referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral vascular surgery, thoracic surgery).
- If planned for only a laparoscopic or endovascular approach (this includes a minimally invasive hybrid approach such as transcarotid artery revascularization), at least one component of the Revised Cardiac Risk Index...
- Colchicine use within one month or history of colchicine intolerance
- Inflammatory bowel disease with history of diarrhea as presentation or chronic diarrhea
- Pre-existent progressive neuromuscular disease
- amyotrophic lateral sclerosis
- hereditary muscular disorders
- myositis
- necrotizing myopathy
- myasthenia gravis
- lambert-eaton syndrome
- Glomerular filtration rate \<30mL/minute or on dialysis
- History of cirrhosis, chronic active hepatitis or severe hepatic disease
- History of myelodysplasia with current evidence of cytopenia
- Active infection defined as fever \>100.4oF or antibiotic use with white blood cell count greater than the upper limit of normal or lower than the lower limit of normal within 24 hours of randomization (major confounder...
- Undergoing immunosuppressive or immunostimulatory chemo or biologic therapy
- Pregnant (as confirmed by urine or serum test), nursing, or planning to become pregnant during study participation
- Participating in a competing study or unable to consent
- Any significant condition or situation that may put the participant at higher risk, confound the study results, or interfere with adherence to study procedures
- Patients on strong CYP3A4 and/or P-glycoprotein inhibitors (e.g., ritonavir, clarithromycin, diltiazem, verapamil) at baseline will also be excluded due to potential drug interactions
- However, if one of these medications are started during the post-operative study period, dose adjustments will be made per drug package insert
- Participants will also be instructed not to drink grapefruit juice while on study drug
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Long Beach, California, United States
- Gainesville, Florida, United States
- Buffalo, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Long Beach, California, United States; Gainesville, Florida, United States; Buffalo, New York, United States; New York, New York, United States; Durham, North Carolina, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.