Colchicine's Effect on Inflammatory Markers

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAyesha Ather

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years and older

Coronary artery bypass graft (CABG) planned procedure

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Colchicine (Colcrys®)
  • Placebo

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ayesha Ather

Lead sponsor

University of Kentucky

Sponsor institution