Aspirin vs Clopidogrel After TAVR

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Aspirin; Clopidogrel

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