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Recruiting Not applicable

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

NCT07411768 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-03-12
Last updated
2026-10-27

Condition(s) studied

Transcatheter Aortic Valve ReplacementTranscatheter Heart Valve ThrombosisAnti-inflammatory Therapy

Investigational drug(s) / intervention(s)

Colchicine →Standard Care

Colchicine: Colchicine 0.5 mg orally once daily for 12 months

Standard Care: Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients

Study summary

This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of Transcatheter Heart Valve (THV) Thrombosis — 1 year
    Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07411768 on ClinicalTrials.gov ↗ ← All trials in China