Anti-inflammatory Therapy, Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGColchicine
Colchicine 0.5 mg orally once daily for 12 months
OTHERStandard Care
Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients
Sponsors
China National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Transcatheter Heart Valve (THV) Thrombosis | 1 year | Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality | 1 month, 1 year | Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality within 1 year |
| Dynamic Changes in Inflammatory/Coagulation Biomarkers | 1 month, 1 year | Dynamic Changes in Inflammatory/Coagulation Biomarkers: Changes in blood markers from baseline to 1 month and 1 year post-TAVR |
| Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities | 1 month, 1 year | Adverse drug reactions: gastrointestinal symptoms (e.g., nausea, diarrhea, vomiting), myalgia, neuritis, skin rash, gout, hospitalization due to infection, new-onset malignancy, etc. Laboratory abnormalities: white blood cell count, absolute neutrophil count, liver and renal function, creatine kinase, etc. |
Countries
China
Contacts
CONTACTYunqing Ye, MD, PhD
Outcome results
None listed