Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Exclusion Criteria

• •Known hypersensitivity, allergy, or documented intolerance to colchicine.
• •Hematologic abnormalities defined as hemoglobin \<80 g/L or white blood cell count \<4.0 × 10⁹/L at screening.
• •Severe renal impairment defined as creatinine clearance \<30 mL/min (calculated by the Cockcroft-Gault formula) or serum creatinine \>2 × upper limit of normal (ULN).
• •Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase \>3 × ULN or total bilirubin \>2 × ULN), or cholestasis.
• •Known history of bone marrow suppression.
• •Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inhibitors, including but not limited to cyclosporine, amiodarone, clarithromycin, erythromycin, omeprazole, or verapamil.
• •Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, or rifampin.
• •Known neuromuscular disorders or creatine kinase (CK) \>3 × ULN at screening.
• •Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea.
• •Active malignancy or history of cancer.
• •Current use of systemic corticosteroids (oral or intravenous) or systemic immunosuppressive agents (topical or inhaled corticosteroids permitted).
• •Acute inflammatory condition or active viral infection at the time of enrollment.
• •Known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• •Estimated life expectancy \<1 year as determined by the investigator.