Aspirin versus clopidogrel for leaflet thrombosis prevention in patients undergoing transcatheter aortic valve replacement: ACLO-TAVR trial

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0007665

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

1.Patients >19 years old
2.Patients who underwent TAVR symptomatic severe AS
3.Provision of informed consent1nt

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of leaflet thrombosis

Secondary Outcome Measures

Name	Time	Method
Any stroke;Ischemic Stroke;Transient ischemic attack;Thromboembolic events (composite of any stroke, myocardial infarction, systemic embolism (not involving the central nervous system), deep-vein thrombosis, or pulmonary embolism);Echocardiographic parameters (maximum and mean aortic valve pressure gradient, doppler velocity index, paravalvular regurgitation, and leaflet thrombosis; at 3 months after TAVR);VARC-3 type 3 or 4 bleeding ;VARC-3 type 2 bleeding