| NCT ID | NCT05493657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Severe Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-02-02 |
| Primary Completion | 2026-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2023-02-02 with a primary completion date of 2026-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Young-Guk Ko, MD, PhD
PRINCIPAL INVESTIGATOR
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Frequently Asked Questions
Who can join the NCT05493657 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Severe Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05493657 currently recruiting?
Yes, NCT05493657 is actively recruiting participants. Contact the research team at ygko@yuhs.ac for enrollment information.
Where is the NCT05493657 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05493657 clinical trial?
NCT05493657 is sponsored by Yonsei University. The principal investigator is Young-Guk Ko, MD, PhD at Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine. The trial plans to enroll 270 participants.