Comparing aspirin use versus no antithrombotic therapy after heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effects of aspirin versus no antithrombotic therapy in patients who have undergone transcatheter aortic valve implantation (TAVI) for aortic stenosis. Participants will be randomly assigned to either receive aspirin 100mg daily starting within 24 hours post-randomization or to a non-antithrombotic group that will not receive any antithrombotic agents throughout the study period. The goal is to assess the safety and efficacy of these two approaches in managing patients post-TAVI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who underwent transfemoral TAVI for aortic stenosis
2. Patients aged 20 years or older at the time of informed consent
3. Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study

Exclusion Criteria:

1. Those with perioperative complications at the time of TAVI (conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction/cerebral hemorrhage, new atrial fibrillation, new atrioventricular block)
2. Individuals requiring antiplatelet agents for reasons other than TAVI (history of myocardial infraction, history of PCI（Percutaneous Coronary Intervention）, history of EVT（EndoVascular Treatment）, history of cerebral infraction and transient ischaemic stroke, with significant coronary artery narrowing, with high-grade carotid artery narrowing, and others judged as requiring antiplatelet therapy by the chief researcher or a sub-investigator)
3. Patients requiring oral anticoagulants (patients with atrial fibrillation, history of pulmonary embolism or deep venous thrombosis, and other patients who are deemed to require anticoagulation therapy by the investigator or coinvestigator)
4. Patients with eGFR（estimated Glomerular Filtration Rate） \<30 and patients on hemodialysis/peritoneal dialysis.
5. Patients with a history of valve replacement in the heart valves.
6. Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding.
7. Patients who have a concomitant medical illness associated with expected survival less than one year.
8. Patients who have the contraindications for aspirin.
9. Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity.
10. Patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study.
11. Other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.

Where it's running

• Keio University Hospital
  Shinjuku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Yosuke Sawa
• Email: sawa.yosuke872@eps.co.jp
• Phone: +81-70-2492-4466

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.