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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

NCT07411768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-03-12

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07411768 on ClinicalTrials.gov