Actively Recruiting
Colchicine's Effect on Inflammatory Markers
Led by Ayesha Ather · Updated on 2026-02-13
24
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.
CONDITIONS
Official Title
Colchicine's Effect on Inflammatory Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Scheduled to have coronary artery bypass graft (CABG) surgery
You will not qualify if you...
- History of atrial fibrillation
- Off-pump CABG procedure
- Current treatment with colchicine for any cause
- Hypersensitivity to colchicine (rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever)
- Emergency cardiac surgery
- Use of extracorporeal membrane oxygenation (ECMO) before or after cardiac surgery
- Heart transplant recipients
- Left ventricular assist device (LVAD) recipients
- Serum creatinine level greater than 2.0 mg/dL
- Elevated preoperative creatine kinase or known muscle disease
- Severe liver disease or liver enzyme levels over 1.5 times the upper limit
- Chronic intestinal disease or blood disorders
- Unable to speak English
- Pregnancy or lactation in women
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucy
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
A
Ayesha Ather
CONTACT
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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