Colchicine's Effect on Inflammatory Markers

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Colchicine, Inflammation in Cardiac Surgery, Post Operative Atrial Fibrillation, Inflammatory Markers, Colchicine Adverse Reaction

In brief

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.

Key facts

Study ID: NCT07287345
Run by: Ayesha Ather
People needed: 24
Starts: 2026-01-16
Expected to finish: 2026-12-30
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years and older
Coronary artery bypass graft (CABG) planned procedure

You may not qualify if…

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 it is running

University of Kentucy — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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