Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT02177266
Eligibility Criteria:
Inclusion Criteria:
* All consecutive adult patients (age \> 40) undergoing standard (non-minimally invasive) coronary artery bypass surgery and/or aortic valve surgery will be approached for enrollment.
* All patients must be able to provide informed consent and comply with the 3 month follow-up.
* For women of reproductive capability, contraception is necessary and required.
Exclusion Criteria:
* Epidermal growth factor receptor (eGFR) \< 30 mL/min/1.73 m\^2, serum creatinine \> 2.5 mg/dL or requiring dialysis
* Known permanent or current atrial fibrillation (history of paroxysmal atrial fibrillation allowed if in sinus rhythm at present)
* Allergy to colchicine or already treated with colchicine.
* Known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia, leukopenia)
* Known serious gastrointestinal disease
* Known severe liver disease (cirrhosis, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2x the upper limit of normal, Model End Stage Liver Disease (MELD) score \> 20)
* Women of childbearing potential not using contraception.
* Patients with HIV or AIDS as the use of protease inhibitors can result in serious colchicine toxicity.
* Patients who are treated with strong CYP3A4 inhibitors (clarithromycin/erythromycin, chloramphenicol, ketoconazole/itraconazole, and nefazodone).
* There is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will exclude patients who require ongoing treatment with digoxin.
* Inability or unwillingness of the individual to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02177266
Study Brief:
Protocol Section:
NCT02177266