Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Launched by OCEAN-SHD STUDY GROUP · Aug 17, 2023

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ClinConnect Summary

This clinical trial is studying the effects of different types of medication after a procedure called Transcatheter Aortic Valve Implantation (TAVI), which is used to treat a heart condition known as aortic stenosis. The trial compares two groups: one that will take 100 mg of aspirin daily after the procedure and another that will not take any antithrombotic (blood-thinning) medication. The goal is to see which approach is better for patients after they have undergone TAVI.

To be eligible for this trial, you must be at least 20 years old and have recently undergone TAVI. However, if you had any serious complications during the procedure, need blood-thinning medications for other medical reasons, or have certain health conditions, you may not be able to participate. If you join the study, you'll be monitored closely to see how your body responds to the assigned treatment, and you'll be helping researchers understand the best care options for patients after TAVI.

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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.