Aspirin vs Clopidogrel After TAVR

Not Applicable

Recruiting

• Conditions: Severe Aortic Stenosis
• Interventions: Drug: Aspirin single antiplatelet therapy; Drug: Clopidogrel single antiplatelet therapy

• Registration Number: NCT05493657
• Lead Sponsor: Yonsei University

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

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-09
• Study Start: 2023-02-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-07-21
• Study Completion: 2027-07-21

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin group	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 group	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.

Primary Outcome Measures

Name	Time	Method
Incidence of leaflet thrombosis	At 3 months after TAVR	Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR

Secondary Outcome Measures

Name	Time	Method
Transient ischemic attack	3 months and 6 months after TAVR
Echocardiographic parameters (maximum and mean aortic valve pressure gradient)	at 3 months after TAVR
Ischemic Stroke	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 (paravalvular regurgitation)	at 3 months after TAVR
VARC-3 type 2 bleeding	3 months and 6 months after TAVR
Any stroke	3 months and 6 months after TAVR
Echocardiographic parameters (doppler velocity index)	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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of