Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement (LoDoCo-TAVR)

A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transcatheter Aortic Valve Replacement; Transcatheter Heart Valve Thrombosis; Anti-inflammatory Therapy
• Intervention / Treatment: Drug: Colchicine; Other: Standard Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunqing Ye, MD, PhD; Phone Number: 8613699282532; Email: judia8510@163.com

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colchicine Group; 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; Colchicine 0.5 mg orally once daily for 12 months; Other: Standard Care; Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients
Active Comparator: Conventional Treatment; 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; Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Transcatheter Heart Valve (THV) Thrombosis	Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality	Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality within 1 year	1 month, 1 year
Dynamic Changes in Inflammatory/Coagulation Biomarkers	Dynamic Changes in Inflammatory/Coagulation Biomarkers: Changes in blood markers from baseline to 1 month and 1 year post-TAVR	1 month, 1 year
Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities	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.	1 month, 1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Heterocyclic Compounds; Quality of Health Care; Alkaloids; Quality Indicators, Health Care; Colchicine; Standard of Care
• Other Study ID Numbers: 2025-I2M-C&T-B-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No