Colchicine's Effect on Inflammatory Markers

NCT07287345 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 102331
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of participants discontinuing treatment

  Through discharge (up to 15 days)

• Change in Liver Function

  Baseline and Post operatively (approximately 24 hours)

• Change in creatinine level

  Baseline through discharge (up to 15 days)

• Creatine kinase level

  Through discharge (up to 15 days)

• Complete blood count (CBC).

  Through discharge (up to 15 days)

Study Arms (2)

Standard of care and placebo

PLACEBO COMPARATOR

placebo capsule

Drug: Placebo

Standard of care and colchicine

EXPERIMENTAL

colchicine capsule

Drug: Colchicine (Colcrys®)

Interventions

Colchicine (Colcrys®) DRUG

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

Standard of care and colchicine

Placebo DRUG

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

Standard of care and placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Coronary artery bypass graft (CABG) planned procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayesha Ather: lead

Study Sites (1)

University of Kentucy

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Sibu Saha, MD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Ayesha Ather

CONTACT

8592184157; ayesha.ather@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)