Aspirin vs Clopidogrel After TAVR | NCT05493657

Studies
Aspirin vs Clopidogrel After TAVR

NCT05493657

Sponsor

Yonsei University

Status

Recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

270Estimated

Phase

Not Applicable

Conditions

Severe Aortic Stenosis

Interventions

Aspirin single antiplatelet therapy
Clopidogrel single antiplatelet therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2023Actual

Primary Completion Date

Jul 21, 2026Estimated

Completion Date

Jul 21, 2027Estimated

First Submitted Date

Aug 8, 2022

First Submission Date that Met QC Criteria

Aug 8, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Prospective, multicenter, open label, randomized controlled study
Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR
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.
Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR
Clinical follow-up up to 6 months

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin group	Active Comparator	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.	Drug: Aspirin single antiplatelet therapy
Clopidogrel group	Experimental	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.	Drug: Clopidogrel single antiplatelet therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin single antiplatelet therapy	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of leaflet thrombosis	Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR	At 3 months after TAVR

Secondary Outcomes

Measure	Description	Time Frame
Any stroke		3 months and 6 months after TAVR
Ischemic Stroke		3 months and 6 months after TAVR
Transient ischemic attack

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >19 years old
Patients who underwent TAVR symptomatic severe AS
Provision of informed consent

Exclusion Criteria:

Patients requiring dual antiplatelet therapy longer than 4 weeks
Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel
History of stroke or transient ischemic attack (TIA) within 6 months
Planned major surgery
Cardiogenic shock or hemodynamic instability
Chronic kidney disease stage 4 or 5 (eGFR <30mL/min)
Valve-in-valve TAVR procedure
Hypersensitivity or contraindication to aspirin or clopidogrel
Indication for anticoagulation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young-Guk Ko, MD, PhD	Contact	82-2-2228-8460		ygko@yuhs.ac

Overall Officials

Name	Affiliation	Role
Young-Guk Ko, MD, PhD	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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