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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
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 score (history of myocardial infarction, history of congestive heart failure, history of transient ischemic attack or stroke, pre-operative use of insulin, pre-operative creatinine >2 mg/dL) should be present
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)
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 below
Select...
I am having a minimally invasive surgery and have at least one heart or stroke risk factor.
Select...
I have had heart surgery or have significant heart artery disease and need a major surgery soon.

POPCORN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-operation for reporting.

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 more

POPCORN 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
1,606 Previous Clinical Trials
3,305,305 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
8,797 Patients Enrolled for Coronary Artery Disease
NYU School of MedicineUNKNOWN
1 Previous Clinical Trials
75 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

Colchicine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05618353 — Phase 4
Coronary Artery Disease Research Study Groups: Colchicine, Placebo
Coronary Artery Disease Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT05618353 — Phase 4
Colchicine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618353 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a current call for participants in this experiment?

"According to clinicaltrials.gov, this medical study is no longer actively recruiting participants; the listing was first posted on May 1st 2023 and most recently edited on November 15th 2022. However, there are still 571 trials seeking volunteers at present."

Answered by AI

How many locations is this experiment taking place in?

"This clinical trial is being conducted in Long Beach, California; Dallas, Texas; Durham, North carolina and 5 other sites. Specifically this research study is based out of VA Long Beach Healthcare System in Los Angeles and the VA North Texas Health Care System Dallas Medical Center as well as the Durham VA Medical Center."

Answered by AI

Does the Federal Drug Administration certify Colchicine for medical use?

"Backed by safety data from a Phase 4 trial, Colchicine received the highest score of 3 on our team's assessment."

Answered by AI
~467 spots leftby Jul 2027