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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin group

    Drug

    Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.

  • Non-antithrombotic group

    Drug

    No antithrombotic agents will be administered after randomization until the end of the study period.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Aspirin groupActive comparator 1 intervention
Group B: Non-antithrombotic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
minimum 2 years, maximum 3 years of follow-up

Secondary outcomes

1

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.

Time frame
minimum 1 year, maximum 3 years of follow-up

Other outcomes

Sponsors and contacts

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