Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.

Inclusion criteria

• Patients with aortic stenosis aged 60-85 years.
• Successful transfemoral TAVR (per VARC-3 criteria).
• Voluntary participation with signed Informed Consent Form.

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.