NCT05493657

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2023Jul 2027

First Submitted

Initial submission to the registry

August 8, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

August 8, 2022

Last Update Submit

January 4, 2026

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of leaflet thrombosis

    Incidence of leaflet thrombosis on cardiac CT at 3 months after TAVR

    At 3 months after TAVR

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

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

Clopidogrel single antiplatelet therapyDRUG

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.

Clopidogrel group
Aspirin single antiplatelet therapyDRUG

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.

Aspirin group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Young-Guk Ko, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Guk Ko, MD, PhD

CONTACT

82-2-2228-8460ygko@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 9, 2022

Study Start

February 2, 2023

Primary Completion (Estimated)

July 21, 2026

Study Completion (Estimated)

July 21, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)