Colchicine's Effect on Inflammatory Markers

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.

Conditions

• Colchicine
• Inflammation in Cardiac Surgery
• Post Operative Atrial Fibrillation
• Inflammatory Markers
• Colchicine Adverse Reaction

Interventions

DRUG

Colchicine (Colcrys®)

Colchicine dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl \>30 mL/min: Colchicine 0.6 mg twice daily If CrCl \<30 mL/min: Colchicine 0.3 mg once daily For patients weighing \<70 kg: If CrCl \>30 mL/min: Colchicine 0.6 mg once daily If CrCl \<30 mL/min: Colchicine 0.3 mg every other day

DRUG

Placebo

Placebo dosing is based on actual body weight and renal function (creatinine clearance). Subjects will initiate study medication (placebo or active drug) 5 days prior to surgery and continue therapy for 10 days postoperatively or until hospital discharge, whichever occurs first. For patients weighing ≥70 kg: If CrCl \>30 mL/min: Placebo 0.6 mg twice daily If CrCl \<30 mL/min: Placebo 0.3 mg once daily For patients weighing \<70 kg: If CrCl \>30 mL/min: Placebo 0.6 mg once daily If CrCl \<30 mL/min: Placebo 0.3 mg every other day

Sponsors & Collaborators

• Ayesha Ather

  lead OTHER

Principal Investigators

• Sibu Saha, MD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-16

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations