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Colchicine's Effect on Inflammatory Markers

RecruitingPhase 4Ages 18 Years - 99 YearsAllAyesha Ather
NCT07287345 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dischar

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📋 Eligibility rules (as published)
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
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What it tests

  • Colchicine (Colcrys®)
  • Placebo
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Where

1 site
University of Kentucy
Lexington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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