Colchicine's Effect on Inflammatory Markers

NCT ID: NCT07287345

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard of care and placebo

placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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 colchicine

colchicine capsule

Group Type: EXPERIMENTAL

Colchicine (Colcrys®)

Intervention Type: 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

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ayesha Ather

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Ather

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Sekela, MD

Role: STUDY_DIRECTOR

University of Kentucky

Locations

University of Kentucy

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ayesha Ather

Role: CONTACT

ayesha.ather@uky.edu

8592184157

Facility Contacts

Ayesha Ather

Role: primary

ayesha.ather@uky.edu

4067214036

Other Identifiers

102331

Identifier Type: -

Identifier Source: org_study_id