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NCT Number: NCT07287345

Colchicine's Effect on Inflammatory Markers

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucy

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Ayesha Ather

CONTACT

[email protected]

4067214036

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change in Inflammatory markers

    Time frame: Baseline (pre-surgery), 24, 48, 72, 96 hours post-surgery and 10 days postoperatively or at discharge, whichever occurs first.

    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.

  2. Rate of post-operative atrial fibrillation (POAF)

    Time frame: Through discharge (up to 15 days)

    Postoperative atrial fibrillation (POAF) incidence will be assessed through daily chart review.

Secondary outcomes

  1. Number of participants discontinuing treatment

    Time frame: Through discharge (up to 15 days)

    treatment discontinuation rates due to adverse events will be measured

  2. Change in Liver Function

    Time frame: Baseline and Post operatively (approximately 24 hours)

    Assessed as the impact on clinical biomarkers, i.e., ALT, AST in units per liter.

  3. Change in creatinine level

    Time frame: Baseline through discharge (up to 15 days)

    Assessed as the impact on clinical biomarkers, i.e., creatinine level in mg/dl

  4. Creatine kinase level

    Time frame: Through discharge (up to 15 days)

    Assessed as the impact on clinical biomarkers, creatine kinase (i.e., CK level) in units per liter

  5. Complete blood count (CBC).

    Time frame: Through discharge (up to 15 days)

    Assessed as the impact on clinical biomarker complete blood count (CBC).

Study contacts

Contact information is provided by the study sponsor or research team.

Ayesha Ather

CONTACT

[email protected]

8592184157

Sponsors and collaborators

Lead sponsor

Ayesha Ather

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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