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Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

NCT05375474 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2023-10-23

No results posted yet for this study

Summary

This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.

Conditions

  • Transcatheter Aortic Valve Replacement
  • Antithrombotic Therapy
  • Bioprosthetic Valve Thrombosis

Interventions

DRUG

Oral anticoagulation therapy

Vitamin-K antagonists (warfarin)

DRUG

Single antiplatelet therapy

Aspirin

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Yongjian Wu, MD,PhD · Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  • Yunqing Ye, Master · Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

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 NCT05375474 on ClinicalTrials.gov