Colchicine's Effect on Inflammatory Markers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colchicine (Colcrys®), Placebo.
- Who it may be relevant to
- Registry conditions: Colchicine, Inflammation in Cardiac Surgery, Post Operative Atrial Fibrillation, Inflammatory Markers. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study
Overview
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.
Interventions
- 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 - 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 \<3
Primary outcome measures
- 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)]
Secondary outcome measures (5)
- Number of participants discontinuing treatment [Time frame: Through discharge (up to 15 days)]
- Change in Liver Function [Time frame: Baseline and Post operatively (approximately 24 hours)]
- Change in creatinine level [Time frame: Baseline through discharge (up to 15 days)]
- Creatine kinase level [Time frame: Through discharge (up to 15 days)]
- Complete blood count (CBC). [Time frame: Through discharge (up to 15 days)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucy — Lexington
Identifiers
NCT: NCT07287345 · 102331