What is the mechanism of action of this treatment?

Common treatments for Coronary Artery Disease (CAD) include anti-inflammatory agents like colchicine, which reduce inflammation in the arteries by targeting inflammatory cells, thereby lowering the risk of cardiac events. Statins are also used to lower cholesterol and have anti-inflammatory effects. Antiplatelet agents such as aspirin prevent blood clots, while beta-blockers and ACE inhibitors reduce the heart's workload and improve blood flow. These treatments are essential for managing symptoms, preventing complications, and enhancing cardiovascular health in CAD patients.

What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) with anti-inflammatory effects, such as colchicine and aspirin, have notable side effects. Colchicine can cause gastrointestinal issues like diarrhea, nausea, and abdominal pain. Aspirin, while beneficial for its anti-inflammatory properties, can increase the risk of gastrointestinal bleeding and other bleeding complications. NSAIDs, another class of anti-inflammatory drugs, may also lead to gastrointestinal problems and heightened cardiovascular risk. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

FDA-approved treatments for Coronary Artery Disease (CAD) that have anti-inflammatory effects similar to colchicine include statins, which lower cholesterol and reduce inflammation, and anti-platelet agents like aspirin, which prevent blood clots and have anti-inflammatory properties. TNF-alpha inhibitors, though primarily used for autoimmune conditions, have also shown potential in reducing cardiovascular events by mitigating inflammation.

What other types of research exist?

Promising novel alternatives to colchicine for CAD patients include: 1) Anti-inflammatory agents being evaluated in placebo-controlled clinical trials in the USA and Canada, which target inflammation to reduce cardiovascular events and risks. 2) Sesamin, which has shown potential in preclinical and clinical investigations for its anti-inflammatory and immune-modulatory effects. These alternatives may offer new therapeutic options for managing inflammation in CAD patients.

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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

Must not have

Pre-existent progressive neuromuscular disease (amyotrophic lateral sclerosis, hereditary muscular disorders, myositis, necrotizing myopathy, myasthenia gravis, lambert-eaton syndrome)

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 with increased inflammatory markers)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-operation

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests colchicine, an anti-inflammatory medication, on patients with previous heart surgeries undergoing major non-heart surgeries. The aim is to see if colchicine can reduce the risk of heart attacks and strokes by lowering inflammation. Colchicine has been shown to reduce the risk of cardiovascular events in patients with coronary artery disease due to its anti-inflammatory properties.

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had heart surgery or have significant heart artery disease and need a major surgery soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a progressive muscle or nerve disease like ALS or muscular dystrophy.

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I do not have an active infection with fever or abnormal white blood cell counts.

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My kidney function is very low or I am on dialysis.

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I am not taking medications like ritonavir, clarithromycin, diltiazem, or verapamil.

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I have a history of severe liver disease.

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I have a history of inflammatory bowel disease with chronic diarrhea.

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I have taken colchicine or am intolerant to it within the last month.

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I am currently receiving therapy that affects my immune system.

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I have a history of myelodysplasia and currently have low blood cell counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-operation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major adverse cardiovascular events

Secondary study objectives

Change in hsCRP

Myocardial Reperfusion Injury

Unplanned coronary revascularization

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include anti-inflammatory agents like colchicine, which reduce inflammation in the arteries by targeting inflammatory cells, thereby lowering the risk of cardiac events. Statins are also used to lower cholesterol and have anti-inflammatory effects. Antiplatelet agents such as aspirin prevent blood clots, while beta-blockers and ACE inhibitors reduce the heart's workload and improve blood flow. These treatments are essential for managing symptoms, preventing complications, and enhancing cardiovascular health in CAD patients.