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NCT Number: NCT05493657

Aspirin vs Clopidogrel After TAVR

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.

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Key information

Conditions

Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Young-Guk Ko, MD, PhD

CONTACT

[email protected]

82-2-2228-8460

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Clopidogrel single antiplatelet therapy

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.

Primary outcomes

  1. Incidence of leaflet thrombosis

    Time frame: At 3 months after TAVR

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

Secondary outcomes

  1. Any stroke

    Time frame: 3 months and 6 months after TAVR

  2. Ischemic Stroke

    Time frame: 3 months and 6 months after TAVR

  3. Transient ischemic attack

    Time frame: 3 months and 6 months after TAVR

  4. Thromboembolic events (composite of any stroke, myocardial infarction, systemic embolism (not involving the central nervous system), deep-vein thrombosis, or pulmonary embolism)

    Time frame: 3 months and 6 months after TAVR

  5. Echocardiographic parameters (maximum and mean aortic valve pressure gradient)

    Time frame: at 3 months after TAVR

  6. Echocardiographic parameters (doppler velocity index)

    Time frame: at 3 months after TAVR

  7. Echocardiographic parameters (paravalvular regurgitation)

    Time frame: at 3 months after TAVR

  8. Echocardiographic parameters (leaflet thrombosis)

    Time frame: at 3 months after TAVR

  9. VARC-3 type 3 or 4 bleeding

    Time frame: 3 months and 6 months after TAVR

  10. VARC-3 type 2 bleeding

    Time frame: 3 months and 6 months after TAVR

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Guk Ko, MD, PhD

CONTACT

[email protected]

82-2-2228-8460

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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