Colchicine for Inflammation After Heart Surgery

Overseen By Ayesha Ather

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ayesha Ather

Must not be taking: Colchicine

Disqualifiers: Atrial fibrillation, Emergency surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 10 days

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether colchicine can reduce inflammation and prevent irregular heartbeat (atrial fibrillation) in individuals undergoing heart bypass surgery. Participants will receive either colchicine or a placebo (a look-alike capsule with no medicine) alongside their usual care. The trial aims to determine if colchicine can lower inflammation markers and reduce the risk of atrial fibrillation after surgery. Adults scheduled for coronary artery bypass surgery who have not previously experienced atrial fibrillation may be suitable for this study. As a Phase 4 trial, colchicine is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for colchicine?

Research shows that colchicine is generally safe for patients undergoing heart surgery. Studies have found that it can lower inflammation and reduce the risk of atrial fibrillation, an irregular heartbeat, after surgery. Some trials reported it as a safe method to prevent this common post-surgery issue.

Colchicine usually causes mild side effects, such as an upset stomach or diarrhea, while serious side effects are rare. Notably, the FDA has already approved colchicine for other uses, indicating a good safety record in people. Overall, evidence suggests colchicine is a safe option for this treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for inflammation after heart surgery typically involve standard anti-inflammatory medications like NSAIDs or corticosteroids. However, colchicine offers a unique approach. Unlike these standard treatments, colchicine targets microtubule polymerization, which plays a key role in the inflammatory process, potentially reducing inflammation more effectively. Researchers are excited about colchicine because it might offer a more targeted, efficient way to manage inflammation, with possibly fewer side effects compared to traditional therapies. This targeted mechanism could lead to improved recovery outcomes for patients undergoing heart surgery.

What evidence suggests that colchicine might be an effective treatment for inflammation after heart surgery?

Research has shown that colchicine can reduce inflammation and prevent atrial fibrillation after heart surgery. In this trial, some participants will receive colchicine alongside standard care, while others will receive a placebo. Studies have found that patients taking colchicine around the time of surgery are less likely to develop this irregular heartbeat. Colchicine's strong anti-inflammatory effects help calm the body's response after surgery. Additionally, some research has found colchicine helpful in treating other heart-related issues, such as pericarditis and certain coronary diseases. Overall, colchicine's ability to reduce inflammation makes it a promising option for patients undergoing heart surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Michael Sekela, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Adults scheduled for coronary artery bypass surgery (CABG) can participate in this study. The trial is designed to assess if colchicine reduces inflammation and the risk of atrial fibrillation post-surgery.

Inclusion Criteria

I am scheduled for a heart bypass surgery.

I am 18 years old or older.

Exclusion Criteria

Serum creatinine >2.0 mg/dL

Unable to speak English

Pregnancy or lactation in women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either colchicine or placebo along with standard care. Blood samples and health information are collected at various time points.

10 days

Visits at baseline, 24, 48, 72, 96 hours post-surgery, and 10 days postoperatively or at discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of inflammatory markers and atrial fibrillation incidence.

Up to 15 days

What Are the Treatments Tested in This Trial?

Interventions

• Colchicine

Trial Overview

The trial tests whether colchicine, compared to a placebo, affects inflammatory markers and prevents irregular heartbeats after heart surgery. Participants are randomly assigned to receive either colchicine or a placebo without knowing which one they get.

How Is the Trial Designed?

Group I: Standard of care and colchicine Experimental Treatment 1 Intervention

colchicine capsule

Group II: Standard of care and placebo Placebo Group 1 Intervention

placebo capsule

Who Is Running the Clinical Trial?

Ayesha Ather

Lead Sponsor

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002914924006532

Colchicine in Patients With Coronary Disease Who ...

This meta-analysis of randomized studies suggests that the perioperative administration of colchicine is associated with significant reduction of POAF after ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9604685/

Colchicine in Cardiac Surgery: The COCS Randomized ...

Colchicine can be effective for the prevention of POAF due to its anti-inflammatory properties. Several studies assessed the effect of ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/ATVBAHA.124.319851

Colchicine's Role in Cardiovascular Disease Management

Randomized clinical trials established low-dose colchicine as an effective treatment for pericarditis and atherosclerotic cardiovascular disease ...

4.

academic.oup.com

academic.oup.com/europace/article/25/7/euad169/7204264

Safety and efficacy of colchicine for the prevention of post ...

Colchicine has been tested and evaluated in several randomized clinical trials (RCTs) to prevent POAF in patients undergoing cardiac surgery.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04224545

NCT04224545 | COlchicine in Cardiac Surgery

Colchicine possesses both anti-inflammatory and sympatholytic properties, so it has been studied to prevent POAF. The ACC/AHA guidelines for colchicine contain ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10318383/

Safety and efficacy of colchicine for the prevention of post ...

Colchicine is an anti-inflammatory drug that may prevent post-operative atrial fibrillation (POAF). The effect of this drug has been inconsistently shown in ...

7.

frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1032116/full

Colchicine for prevention of post-operative atrial fibrillation

Our study demonstrates that colchicine is a useful and safe agent for prevention of post-operative AF. Although in post lung surgery subgroup, ...