Recruiting

Colchicine

Sponsor:

Ayesha Ather

Code:

NCT07287345

Conditions

Colchicine

Inflammation in Cardiac Surgery

Post Operative Atrial Fibrillation

Inflammatory Markers

Colchicine Adverse Reaction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Colchicine (Colcrys®)

Placebo

Study Details

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

Study ID

NCT07287345

Start date

Jan 16, 2026

Status verified date

Jun, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard of care and placebo

placebo capsule

experimental: Standard of care and colchicine

colchicine capsule

Interventions

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

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

Primary outcome measure

  • 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. ]
  • Rate of post-operative atrial fibrillation (POAF) [ Time Frame: Through discharge (up to 15 days) ]

Central Contacts and Locations

Central contacts

Ayesha Ather

8592184157ayesha.ather@uky.edu

Locations

University of Kentucy

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Ayesha Ather

4067214036ayesha.ather@uky.edu

More Information

Sponsor

Ayesha Ather

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ayesha Ather on 2026-06-25.