Colchicine's Effect on Inflammatory Markers

Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Markers; Colchicine; Colchicine Adverse Reaction; Post Operative Atrial Fibrillation; Inflammation in Cardiac Surgery
• Intervention / Treatment: Drug: Placebo; Drug: Colchicine (Colcrys®)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ayesha Ather; Phone Number: 8592184157; Email: ayesha.ather@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University Of Kentucy
      • Contact: Ayesha Ather; Phone Number: 4067214036; Email: ayesha.ather@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard of care and placebo; placebo capsule	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
Experimental: Standard of care and colchicine; colchicine capsule	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory markers	markers of inflammation (IL-6, CRP, IL-18, IL-1β, IL-8, and TNF-α) will be measured at predefined time points. Blood samples will be obtained as part of routine clinical care and analyzed using commercially available ELISA assays.	Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.
Rate of post-operative atrial fibrillation (POAF)	Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.	Through discharge (up to 15 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants discontinuing treatment	treatment discontinuation rates due to adverse events will be measured	Through discharge (up to 15 days)
Change in Liver Function	Assessed as the impact on clinical biomarkers, i.e., ALT, AST in units per liter.	Baseline and Post operatively (approximately 24 hours)
Change in creatinine level	Assessed as the impact on clinical biomarkers, i.e., creatinine level in mg/dl	Baseline through discharge (up to 15 days)
Creatine kinase level	Assessed as the impact on clinical biomarkers, creatine kinase (i.e., CK level) in units per liter	Through discharge (up to 15 days)
Complete blood count (CBC).	Assessed as the impact on clinical biomarker complete blood count (CBC).	Through discharge (up to 15 days)

Collaborators and Investigators

• Sponsor: Ayesha Ather
• Investigators: Study Director: Sibu Saha, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Alkaloids; Colchicine
• Other Study ID Numbers: 102331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes