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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement | Clinical Trials | Clareo Health

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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

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

NCT07411768•China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - 85 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (1)

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

Beijing, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

March 12, 2026

Enrollment

116

ESTIMATED participants

Conditions

Transcatheter Aortic Valve ReplacementTranscatheter Heart Valve ThrombosisAnti-inflammatory Therapy

Interventions

Colchicine

DRUG

Standard Care

OTHER

Contacts

Yunqing Ye, MD, PhD

CONTACT

8613699282532 judia8510@163.com

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RECRUITING

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Inclusion Criteria

Exclusion Criteria

Short Versus Long Antiplatelet Therapy After TAVI

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

The Sentinel Registry

Intra-procedural ECG Changes During TAVR