Colchicine to lower inflammation and prevent atrial fibrillation after coronary bypass
Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study
This trial tests whether giving colchicine to adults having coronary artery bypass (CABG) can lower inflammation and reduce the chance of atrial fibrillation after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT07287345 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for on-pump coronary artery bypass grafting are randomly assigned to receive either colchicine or a matching placebo in a double-blind fashion alongside usual care. Participants take a study capsule and have blood drawn before surgery, at 24, 48, 72, and 96 hours after surgery, and again at 10 days or hospital discharge to measure inflammatory markers. The study compares marker levels and the occurrence of new-onset postoperative atrial fibrillation between the colchicine and placebo groups. Safety monitoring includes assessment of colchicine-related adverse reactions and routine clinical follow-up while hospitalized.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for on-pump coronary artery bypass grafting who do not have a history of atrial fibrillation, are not currently taking colchicine, and meet the kidney, liver, and other medical criteria are ideal candidates.
Not a fit: Patients with prior atrial fibrillation, off-pump CABG, severe renal or hepatic dysfunction, current colchicine use, emergency surgery, ECMO, heart transplant, LVAD, chronic intestinal disease, blood dyscrasia, pregnancy or inability to speak English are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, colchicine could reduce postoperative inflammation and lower the rate of new-onset atrial fibrillation after CABG, potentially shortening hospital stays and reducing complications.
How similar studies have performed: Colchicine has demonstrated benefit in inflammatory cardiac conditions such as pericarditis and shown positive signals in some coronary disease studies, but evidence for preventing postoperative atrial fibrillation is mixed and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older * Coronary artery bypass graft (CABG) planned procedure Exclusion Criteria: * History of atrial fibrillation * Off-pump CABG procedure * Current treatment with colchicine for any cause * Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever) * Emergency cardiac surgery * Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery * Heart transplant patients * Left ventricular assist device (LVAD) patients * Serum creatinine \>2.0 mg/dL * Preoperative elevated CK or known myopathy * Severe liver disease or elevation of serum transaminases (\>1.5 times the upper limit of 40 units/liter) * Chronic intestinal disease or blood dyscrasia * Unable to speak English * Pregnancy or lactation in women
Where this trial is running
Lexington, Kentucky
- University of Kentucy — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Ayesha Ather
- Email: ayesha.ather@uky.edu
- Phone: 8592184157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.