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Aspirin vs Clopidogrel After TAVR

ConditionSevere Aortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >19 years old

Patients who underwent TAVR symptomatic severe AS

Provision of informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Aspirin groupActive comparator 1 intervention
Group B: Clopidogrel groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of leaflet thrombosis

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

Time frame
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

Other outcomes

Sponsors and contacts

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Yonsei University

Lead sponsor

Source ClinicalTrials.gov
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