NCT07287345 Colchicine's Effect on Inflammatory Markers
| NCT ID | NCT07287345 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ayesha Ather |
| Condition | Colchicine |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 24 participants in total. It began in 2026-01-16 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sibu Saha, MD
STUDY DIRECTOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT07287345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Colchicine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07287345 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07287345 currently recruiting?
Yes, NCT07287345 is actively recruiting participants. Contact the research team at ayesha.ather@uky.edu for enrollment information.
Where is the NCT07287345 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT07287345 clinical trial?
NCT07287345 is sponsored by Ayesha Ather. The principal investigator is Sibu Saha, MD at University of Kentucky. The trial plans to enroll 24 participants.