Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorOCEAN-SHD Study Group

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

Qualifiers

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

Treatments tested in this trial

  • Aspirin group
  • Non-antithrombotic group

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators