Aspirin vs Clopidogrel After TAVR

NCT ID: NCT05493657

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2027-07-21

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

Conditions

Severe Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin group

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.

Group Type: ACTIVE_COMPARATOR

Aspirin single antiplatelet therapy

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Clopidogrel single antiplatelet therapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Guk Ko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Young-Guk Ko, MD, PhD

Role: CONTACT

ygko@yuhs.ac

82-2-2228-8460

Facility Contacts

Young-Guk Ko, MD, PhD

Role: primary

ygko@yuhs.ac

82-2-2228-8460

Other Identifiers

4-2022-0744

Identifier Type: -

Identifier Source: org_study_id