Actively Recruiting
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Led by OCEAN-SHD Study Group · Updated on 2024-09-23
400
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who underwent transfemoral TAVI for aortic stenosis
- Patients aged 20 years or older at the time of informed consent
- Patients who understand the study and have agreed in writing to participate
You will not qualify if you...
- Patients with perioperative complications at the time of TAVI such as conversion to open heart surgery, coronary artery occlusion, annulus rupture, cardiac tamponade, vascular dissection, cerebral infarction or hemorrhage, new atrial fibrillation or atrioventricular block
- Patients requiring antiplatelet agents for reasons other than TAVI, including history of myocardial infarction, PCI, EVT, cerebral infarction or transient ischemic attack, significant coronary or carotid artery narrowing, or judged to require antiplatelet therapy
- Patients requiring oral anticoagulants due to atrial fibrillation, pulmonary embolism, deep venous thrombosis, or other reasons
- Patients with estimated glomerular filtration rate (eGFR) less than 30 or on hemodialysis/peritoneal dialysis
- Patients with a history of heart valve replacement
- Patients who are pregnant, breastfeeding, have childbearing potential, or wish to become pregnant
- Patients with serious medical illness with expected survival less than one year
- Patients with contraindications or severe allergy to aspirin
- Patients requiring a legally acceptable representative or unable to provide informed consent or understand the study
- Other patients deemed inappropriate for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Keio University Hospital
Shinjuku, Tokyo, Japan, 160-8582
Actively Recruiting
Research Team
Y
Yosuke Sawa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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