Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation 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.
| Condition(s) | Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin, DAPT(Dual Antiplatelet Therapy), SAPT(Single Antiplatelet Therapy) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 i |
| Ages | 20 Years |
| Sex | All |
| Lead sponsor | OCEAN-SHD Study Group |
| Locations | Shinjuku, Tokyo, Japan |
| Start date | 2023-04-06 |
| NCT ID | NCT06007222 |
| Official listing | https://clinicaltrials.gov/study/NCT06007222 |