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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucy
Lexington 4297983, Kentucky 6254925 40536
Contact:
Ayesha Ather
4067214036
ayesha.ather@uky.edu

More Details

NCT ID
NCT07287345
Status
Recruiting
Sponsor
Ayesha Ather

Study Contact

Ayesha Ather
8592184157
ayesha.ather@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.