Severe Aortic Stenosis
Conditions
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.
Detailed description
1. Prospective, multicenter, open label, randomized controlled study 2. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR 3. All 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. 4. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR 5. Clinical follow-up up to 6 months
Interventions
DRUGAspirin 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.
DRUGClopidogrel 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of leaflet thrombosis | At 3 months after TAVR | Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke | 3 months and 6 months after TAVR |
| Ischemic Stroke | 3 months and 6 months after TAVR |
| Transient ischemic attack | 3 months and 6 months after TAVR |
| Thromboembolic events (composite of any stroke, myocardial infarction, systemic embolism (not involving the central nervous system), deep-vein thrombosis, or pulmonary embolism) | 3 months and 6 months after TAVR |
| Echocardiographic parameters (maximum and mean aortic valve pressure gradient) | at 3 months after TAVR |
| Echocardiographic parameters (doppler velocity index) | at 3 months after TAVR |
| Echocardiographic parameters (paravalvular regurgitation) | at 3 months after TAVR |
| Echocardiographic parameters (leaflet thrombosis) | at 3 months after TAVR |
| VARC-3 type 3 or 4 bleeding | 3 months and 6 months after TAVR |
| VARC-3 type 2 bleeding | 3 months and 6 months after TAVR |
Countries
South Korea
Contacts
CONTACTYoung-Guk Ko, MD, PhD
PRINCIPAL_INVESTIGATORYoung-Guk Ko, MD, PhD
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Outcome results
None listed