Colchicine's Effect on Inflammatory Markers

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Ayesha Ather
Study ID
NCT07287345
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Standard of care and placebo
    placebo capsule
  • Experimental: Standard of care and colchicine
    colchicine capsule

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentucyLexingtonKentucky40536
Ayesha Ather
[email protected]
4067214036

Find similar trials in Lexington, KY

By research site
University of Kentucy· Lexington, KY

Related Studies