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Clinical Trials in South Korea / NCT05493657
Recruiting Not applicable

Aspirin vs Clopidogrel After TAVR

NCT05493657 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2023-02-02
Last updated
2026-06-30

Condition(s) studied

Severe Aortic Stenosis

Investigational drug(s) / intervention(s)

Aspirin single antiplatelet therapyClopidogrel single antiplatelet therapy

Aspirin single antiplatelet therapy: Patients receive the aspirin (100 mg/day) single antiplatelet therapy after 4 weeks of dual antiplatelet therapy of aspirin (100 mg/day) and clopidogrel (75 mg/day) after TAVR.

Clopidogrel single antiplatelet therapy: Patients receive the clopidogrel (75 mg/day) single antiplatelet therapy after 4 weeks of dual antiplatelet therapy of aspirin (100 mg/day) and clopidogrel (75 mg/day) after TAVR.

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients \>19 years old 2. Patients who underwent TAVR symptomatic severe AS 3. Provision of informed consent Exclusion Criteria: 1. Patients requiring dual antiplatelet therapy longer than 4 weeks 2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel 3. History of stroke or transient ischemic attack (TIA) within 6 months 4. Planned major surgery 5. Cardiogenic shock or hemodynamic instability 6. Chronic kidney disease stage 4 or 5 (eGFR \<30mL/min) 7. Valve-in-valve TAVR procedure 8. Hypersensitivity or contraindication to aspirin or clopidogrel 9. Indication for anticoagulation therapy

Primary outcome measure(s)

  • Incidence of leaflet thrombosis — At 3 months after TAVR
    Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting

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Other trials for the same condition

Angiotensin Receptor Blocker After TAVR in Severe Aortic Stenosis With Left Ventricular Hypertrophy (ARBITAR) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05493657 on ClinicalTrials.gov ↗ ← All trials in South Korea