Low-dose Colchicine for CABG Graft Failure Prevention
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 Pill, Placebo.
- Who it may be relevant to
- Registry conditions: CAD - Coronary Artery Disease, CABG, Colchicine. Basic parameters: from 18 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
- China
- 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
Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.
Interventions
- Drug Colchicine Pill
Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months. - Drug Placebo
Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Primary outcome measures
- graft failure rate [Time frame: 2 year after randomization]
Secondary outcome measures (1)
- MACCE [Time frame: 2 year after randomization]
Eligibility criteria
Inclusion criteria
- Be male or female, aged 18 years or older;
- Within 3 days after successful isolated coronary artery bypass grafting (CABG);
- Sign informed consent;
Exclusion criteria
- Severe valvular heart disease requiring concomitant or staged valvular surgery;
- History of non-skin cancer in the past 3 years;
- Inflammatory bowel disease or chronic diarrhea;
- Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
- Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities (Hemoglobin <100g/L or hematocrit < 30% or > 52% or white blood cell count < 3×109/L or platelet count < 100×109/L);
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (based on the CKDEPI formula);
- Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range, accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders (INR>1.5) (except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);
- Decline in cognitive function due to inability to perform basic activities of daily living independently;
- Drug or alcohol abuse;
- Other immunosuppressive therapies already in existence or planned;
- Other causes require long-term colchicine treatment;
- History of clear or suspected colchicine allergy;
- Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.
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
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT07569328 · TACTIC-II