Comparing aspirin use versus no antithrombotic therapy after heart valve replacement

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

This study tests whether taking aspirin after heart valve replacement helps patients feel better compared to not taking any blood-thinning medicine.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: OCEAN-SHD Study Group (Academic / other)
• Locations: 1 site (Shinjuku, Tokyo)
• Trial ID: NCT06007222 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20 years or older who have undergone transfemoral TAVI for aortic stenosis.

Not a fit: Patients with perioperative complications or those requiring antiplatelet agents for other medical reasons may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimal post-operative care for patients undergoing TAVI, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored antithrombotic therapies in similar contexts, but this specific comparison of aspirin versus no therapy post-TAVI is relatively novel.

Eligibility criteria

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 this trial is running

Shinjuku, Tokyo

• Keio University Hospital — Shinjuku, Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Yosuke Sawa

Conditions Aortic Stenosis; TAVI; Aspirin; DAPT; SAPT