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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on patients with aortic stenosis who have undergone transfemoral transcatheter aortic valve implantation (TAVI). It evaluates the use of aspirin compared to no antithrombotic agents after the procedure. The study is a phase 4, randomized trial aiming to assess the outcomes of these two approaches over a long follow-up period. Participants are assigned to one of two groups: the aspirin group, which starts aspirin 100mg within 24 hours after randomization and continues daily until the study ends; or the non-antithrombotic group, which receives no antithrombotic agents throughout the study. The trial monitors patients for a minimum of two years and up to three years. During the study, patients will be regularly followed to observe the primary endpoint over 2 to 3 years, along with key secondary outcomes tracked for at least 1 year. Researchers will assess safety and efficacy measures related to aspirin use or its absence after TAVI. Participation lasts for the full follow-up period, with ongoing evaluations to understand treatment impacts.
CONDITIONS
Brief 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 agree in writing to participate
You will not qualify if you...
- Perioperative complications at the time of TAVI, such as open heart surgery conversion or new heart rhythm problems
- Need for antiplatelet agents for reasons other than TAVI, including history of myocardial infarction or stroke
- Need for oral anticoagulants, including atrial fibrillation or history of blood clots
- Estimated Glomerular Filtration Rate (eGFR) less than 30 or on dialysis
- History of heart valve replacement
- Pregnancy, breastfeeding, or desire to become pregnant
- Medical illness with expected survival under one year
- Contraindications or severe allergy to aspirin
- Inability to provide informed consent or understand the study
- Other reasons judged by investigators as inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum 2 years, maximum 3 years
Participants receive either aspirin 100mg daily starting within 24 hours after randomization or no antithrombotic therapy, continuing until the end of the study period.
Regular visits as per study protocol
Trial Site Locations
Total: 1 location
1
Keio University Hospital
Shinjuku, Tokyo, Japan, 160-8582
Actively Recruiting
Research Team
Y
Yosuke Sawa
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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