Colchicine's Effect on Inflammatory Markers

Ayesha Ather

Status and phase: Enrolling; Phase 4

Conditions: Inflammation in Cardiac Surgery; Colchicine; Inflammatory Markers; Post Operative Atrial Fibrillation; Colchicine Adverse Reaction

Treatments: Drug: Colchicine (Colcrys®); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07287345

102331

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Standard of care and placebo

Placebo Comparator group

Description:

placebo capsule

Treatment:

Drug: Placebo

Standard of care and colchicine

Experimental group

Description:

colchicine capsule

Treatment:

Drug: Colchicine (Colcrys®)