Actively Recruiting
Adjunctive Colchicine's Effect on Inflammatory Markers and New-Onset Atrial Fibrillation Rates After Coronary Artery Bypass Graft Surgery: A Pilot Study
Led by Ayesha Ather · Updated on 2026-06-08
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the medicine colchicine can reduce inflammation and lower the chance of developing an irregular heartbeat called atrial fibrillation after coronary artery bypass surgery (CABG) in adults. This Phase 4 pilot study will compare colchicine plus usual care to a placebo plus usual care to gather safety data and effect estimates that can help plan larger future studies. Participants will be randomly assigned to take either colchicine capsules or placebo capsules starting 5 days before their surgery and continuing for 10 days after surgery or until hospital discharge, whichever comes first. The colchicine dose depends on body weight and kidney function. Both groups receive usual care alongside the study capsules, and neither participants nor study staff will know who receives colchicine or placebo. Participants will provide blood samples and health information before surgery, then at 24, 48, 72, and 96 hours after surgery, and again at 10 days post-surgery or discharge. Researchers will measure inflammation markers, track new cases of atrial fibrillation, monitor liver and kidney function, blood counts, and note any side effects. The study lasts through hospital discharge, which can be up to 15 days after surgery.
CONDITIONS
Brief Title
Colchicine's Effect on Inflammatory Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Planned coronary artery bypass graft (CABG) surgery procedure
You will not qualify if you...
- History of atrial fibrillation
- Off-pump CABG procedure
- Current treatment with colchicine for any reason
- Hypersensitivity to colchicine (rash, hives, itching, red or swollen skin with or without fever)
- Emergency cardiac surgery
- Use of Extracorporeal Membrane Oxygenation (ECMO) before or after surgery
- Heart transplant patients
- Left ventricular assist device (LVAD) patients
- Serum creatinine greater than 2.0 mg/dL
- Elevated creatine kinase or known muscle disease before surgery
- Severe liver disease or elevated liver enzymes above 1.5 times the upper limit
- Chronic intestinal disease or blood disorders
- Unable to speak English
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 days before surgery
Participants start taking the study medication (colchicine or placebo) 5 days prior to coronary artery bypass graft surgery.
1 visit (in-person) before surgery
Duration - 10 days postoperatively or until discharge
Participants continue taking the study medication for 10 days after surgery or until hospital discharge, whichever occurs first.
Daily medication with monitoring visits through hospital stay (up to 15 days)
Trial Site Locations
Total: 1 location
1
University of Kentucy
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
A
Ayesha Ather
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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