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Colchicine for Coronary Artery Disease (POPCORN Trial)
Phase 4
Recruiting
Led By Binita Shah, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 on coronary angiography), AND referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral vascular surgery, thoracic surgery)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-operation
Awards & highlights
POPCORN Trial Summary
This trial seeks to understand how inflammation in the heart increases risk of complications after surgery & if a medication can reduce this risk, helping reduce heart attack, stroke & death.
Who is the study for?
This trial is for men and women with a history of heart surgery or significant coronary artery disease, who are now facing intermediate- or high-risk surgeries. They must not have used colchicine recently, have inflammatory bowel issues, severe kidney or liver diseases, certain neuromuscular disorders, be pregnant/nursing/planning pregnancy, on specific drugs that interact with colchicine, or have an active infection.Check my eligibility
What is being tested?
The POPCORN Trial is testing whether the anti-inflammatory medication colchicine can reduce complications like heart attack and stroke in patients with heart disease undergoing major surgery compared to a placebo (a substance with no therapeutic effect).See study design
What are the potential side effects?
Colchicine may cause side effects such as digestive problems (nausea, vomiting), blood disorders (low white blood cell count), muscle pain/weakness. It's important to note that individual reactions to the medication can vary.
POPCORN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had heart surgery or have significant heart artery disease and need a major surgery soon.
POPCORN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major adverse cardiovascular events
Secondary outcome measures
Change in hsCRP
Myocardial Reperfusion Injury
Unplanned coronary revascularization
+4 morePOPCORN Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ColchicineActive Control1 Intervention
One day before surgery: Colchicine 1.2 mg with 0.6 mg PO one hour later. This load will be followed by colchicine 0.6 mg twice daily for a total of 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo at same time points as active comparator
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,322,706 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
9,247 Patients Enrolled for Coronary Artery Disease
NYU School of MedicineUNKNOWN
2 Previous Clinical Trials
513 Total Patients Enrolled
Binita Shah, MDPrincipal InvestigatorManhattan Campus of the VA NY Harbor Healthcare System, New York, NY
4 Previous Clinical Trials
1,316 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
994 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a progressive muscle or nerve disease like ALS or muscular dystrophy.If I start a new medication after surgery, I understand my dose may need adjustments.My kidney function is very low or I am on dialysis.I do not have an active infection with fever or abnormal white blood cell counts.I am not taking medications like ritonavir, clarithromycin, diltiazem, or verapamil.I am having a minimally invasive surgery and have at least one heart or stroke risk factor.I have had heart surgery or have significant heart artery disease and need a major surgery soon.I have a history of severe liver disease.I have a history of inflammatory bowel disease with chronic diarrhea.I have taken colchicine or am intolerant to it within the last month.I am currently receiving therapy that affects my immune system.I have a history of myelodysplasia and currently have low blood cell counts.
Research Study Groups:
This trial has the following groups:- Group 1: Colchicine
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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