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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07411768
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT07411768
Study Brief:
Protocol Section:
NCT07411768