About this trial
Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who underwent transfemoral TAVI for aortic stenosis
Patients aged 20 years or older at the time of informed consent
Patients who have a thorough understanding of the subject of the study and who have agreed in writing to participate in the study
Disqualifiers
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)
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)
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)
Patients with eGFR(estimated Glomerular Filtration Rate) <30 and patients on hemodialysis/peritoneal dialysis.
Trial design
Parallel
Treatments tested in this trial
Aspirin group
DrugAspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
Non-antithrombotic group
DrugNo antithrombotic agents will be administered after randomization until the end of the study period.
Treatment groups
Trial outcomes
Primary outcomes
Primary endpoint
Composite endpoint consisting of all-cause deaths, myocardial infarction, stroke from any cause and bleeding from randomization to end of study The outcomes of this study will comply with the Valve Academic Research Consortium 3 (VARC 3). VARC 3 Type 1, Type 2, Type 3, and Type 4 bleeding are all included as bleeding. In this study, the study subjects will be randomized after it has been confirmed that there were no perioperative complications, so it is essentially assumed that there will be no procedure-related bleeding. Surviving subjects for whom the event does not occur will be censored as of the date the study treatment is discontinued or as of the last confirmed date of survival.
Secondary outcomes
Key Secondary endpoint
Bleeding Events from Randomization to Study End. Cardiovascular adverse events from randomization until the end of the study (composite endpoint comprised of cardiovascular death, myocardial infarction, or CVA). The definition of censoring for survival time analysis is the same as that used for the primary endpoint.
Sponsors and contacts
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