700 Participants Needed

Colchicine for Coronary Artery Disease

(POPCORN Trial)

Recruiting at 6 trial locations
YL
LM
JY
TK
Overseen ByTaj Kaur
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop all current medications. However, you cannot participate if you are on strong CYP3A4 and/or P-glycoprotein inhibitors like ritonavir, clarithromycin, diltiazem, or verapamil at the start. If you start these medications during the study, dose adjustments will be made. Also, avoid grapefruit juice while on the study drug.

What data supports the idea that Colchicine for Coronary Artery Disease is an effective drug?

The available research shows that colchicine is effective in reducing the risk of cardiovascular events in patients with coronary artery disease. For example, the LoDoCo2 trial found that low-dose colchicine significantly reduced the risk of heart-related problems like heart attacks and strokes in patients with stable coronary artery disease. Additionally, a systematic review and meta-analysis confirmed colchicine's protective effects for patients with coronary artery disease. These studies suggest that colchicine can be a beneficial addition to existing treatments for coronary artery disease.12345

What safety data exists for colchicine in treating coronary artery disease?

The LoDoCo2 trial and other studies have evaluated the safety of low-dose colchicine (0.5 mg daily) in patients with coronary artery disease. The LoDoCo2 trial found that colchicine is generally safe, with potential adverse events including gastrointestinal intolerance, neuropathy, myopathy, myositis, and neutropenia. A systematic review and meta-analysis confirmed an increased risk of gastrointestinal events but no significant increase in other adverse events. Another study found no significant impact on renal or liver function or creatine kinase levels after 2-4 years of colchicine use. Overall, colchicine is considered safe for long-term use in this patient population, with gastrointestinal issues being the most common side effect.35678

Is the drug Colchicine a promising treatment for coronary artery disease?

Yes, Colchicine is a promising treatment for coronary artery disease. It has been shown to reduce the risk of heart-related events in patients with this condition. Colchicine is an anti-inflammatory drug that can help prevent heart attacks and strokes by reducing inflammation in the arteries. It is also affordable and has a good safety profile, making it a valuable option for treating coronary artery disease.23459

Research Team

BS

Binita Shah, MD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have a progressive muscle or nerve disease like ALS or muscular dystrophy.
Participating in a competing study or unable to consent
If I start a new medication after surgery, I understand my dose may need adjustments.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Treatment

Participants receive a loading dose of colchicine or placebo one day before surgery

1 day
1 visit (in-person)

Post-surgery Treatment

Participants receive colchicine or placebo twice daily for 14 days post-operation

14 days
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
1 visit (in-person) at 30 days post-operation

Treatment Details

Interventions

  • Colchicine
  • Placebo
Trial OverviewThe 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).
Participant Groups
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

Colchicine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Colcrys for:
  • Gout
  • Familial Mediterranean Fever

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

NYU Grossman School of Medicine

Collaborator

Trials
5
Recruited
2,400+

NYU School of Medicine

Collaborator

Trials
3
Recruited
1,200+

Findings from Research

The CHANCE-3 trial is investigating the efficacy of colchicine in preventing recurrent strokes in 8,238 patients with acute minor-to-moderate ischemic stroke or high-risk transient ischemic attack, aiming for a 25% reduction in stroke events within 3 months.
Colchicine will be administered for 90 days, and the study will also monitor for any adverse events related to the treatment, ensuring a comprehensive assessment of its safety and effectiveness.
Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3): Rationale and design of a multicenter randomized placebo-controlled trial.Wang, Y., Li, J., Johnston, SC., et al.[2023]
A study involving patients with chronic coronary disease demonstrated that colchicine significantly reduced the risk of cardiovascular events, highlighting its potential as an effective treatment option.
The findings suggest that colchicine may work by reducing inflammation, which is a key factor in the progression of coronary disease.
Low-dose colchicine reduced risk for cardiovascular events in chronic coronary disease.Cohn, JN.[2021]
The LoDoCo2 trial is investigating the efficacy and safety of low-dose colchicine (0.5 mg daily) in 5522 patients with stable coronary artery disease, aiming to confirm its potential for secondary prevention of cardiovascular events.
This study is designed to detect a 30% reduction in major cardiovascular events, such as heart attacks and strokes, while also monitoring for any adverse effects related to colchicine, indicating a thorough approach to evaluating its safety and effectiveness.
The effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics.Nidorf, SM., Fiolet, ATL., Eikelboom, JW., et al.[2023]

References

Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3): Rationale and design of a multicenter randomized placebo-controlled trial. [2023]
Low-dose colchicine reduced risk for cardiovascular events in chronic coronary disease. [2021]
The effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics. [2023]
Drug repurposing? Cardiovascular effect of colchicine on patients with coronary artery disease: A systematic review and meta-analysis. [2021]
Drivers of mortality in patients with chronic coronary disease in the low-dose colchicine 2 trial. [2023]
Low-Dose Colchicine in Coronary Artery Disease - Systematic Review and Meta-Analysis. [2021]
Efficacy and Safety of Colchicine in Post-acute Myocardial Infarction Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]
The Effect of Years-Long Exposure to Low-Dose Colchicine on Renal and Liver Function and Blood Creatine Kinase Levels: Safety Insights from the Low-Dose Colchicine 2 (LoDoCo2) Trial. [2022]
Colchicine for acute and chronic coronary syndromes. [2021]