Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT05493657

Aspirin vs Clopidogrel After TAVR

Led by Yonsei University · Updated on 2026-01-07

254

Participants Needed

1

Research Sites

232 weeks

Total Duration

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AI-Summary

What this Trial Is About

Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized controlled study. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR. Patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR. Patients will be clinically followed for 6 months. The primary endpoint is the Incidence of leaflet thrombosis on cardiac CT at 3 months.

CONDITIONS

Official Title

Aspirin vs Clopidogrel After TAVR

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 19 years
  • Patients who have undergone transcatheter aortic valve replacement for symptomatic severe aortic stenosis
  • Willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Need for dual antiplatelet therapy longer than 4 weeks
  • Conditions requiring specific antiplatelet therapy with aspirin or clopidogrel
  • History of stroke or transient ischemic attack within 6 months
  • Planned major surgery
  • Cardiogenic shock or hemodynamic instability
  • Chronic kidney disease stage 4 or 5 (eGFR less than 30 mL/min)
  • Valve-in-valve TAVR procedure
  • Allergy or contraindication to aspirin or clopidogrel
  • Requirement for anticoagulation therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

Y

Young-Guk Ko, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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