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Recruiting NCT05493657

Aspirin vs Clopidogrel After TAVR

No phase Interventional Severe Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin single antiplatelet therapy, Clopidogrel single antiplatelet therapy.
Who it may be relevant to
Registry conditions: Severe Aortic Stenosis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • Incidence of leaflet thrombosis [Time frame: At 3 months after TAVR]
Secondary outcome measures (10)
  • Any stroke [Time frame: 3 months and 6 months after TAVR]
  • Ischemic Stroke [Time frame: 3 months and 6 months after TAVR]
  • Transient ischemic attack [Time frame: 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) [Time frame: 3 months and 6 months after TAVR]
  • Echocardiographic parameters (maximum and mean aortic valve pressure gradient) [Time frame: at 3 months after TAVR]
  • Echocardiographic parameters (doppler velocity index) [Time frame: at 3 months after TAVR]
  • Echocardiographic parameters (paravalvular regurgitation) [Time frame: at 3 months after TAVR]
  • Echocardiographic parameters (leaflet thrombosis) [Time frame: at 3 months after TAVR]
  • VARC-3 type 3 or 4 bleeding [Time frame: 3 months and 6 months after TAVR]
  • VARC-3 type 2 bleeding [Time frame: 3 months and 6 months after TAVR]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT05493657 · 4-2022-0744

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗