Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

NCT07411768 | Not Yet Recruiting

• 1 other identifier: 2025-I2M-C&T-B-026
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacement; Transcatheter Heart Valve Thrombosis; Anti-inflammatory Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Transcatheter Heart Valve (THV) Thrombosis

  Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion

  1 year

Secondary Outcomes (3)

• Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality

  1 month, 1 year

• Dynamic Changes in Inflammatory/Coagulation Biomarkers

  1 month, 1 year

• Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities

  1 month, 1 year

Study Arms (2)

Colchicine Group

EXPERIMENTAL

0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care.

Drug: Colchicine; Other: Standard Care

Conventional Treatment

ACTIVE COMPARATOR

Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine.

Other: Standard Care

Interventions

Colchicine DRUG

Colchicine 0.5 mg orally once daily for 12 months

Colchicine Group

Standard Care OTHER

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

Colchicine Group; Conventional Treatment

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

Location

MeSH Terms

Interventions

Colchicine; Standard of Care

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Yunqing Ye, MD, PhD

CONTACT

8613699282532; judia8510@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)