NCT06007222 Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
| NCT ID | NCT06007222 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | OCEAN-SHD Study Group |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-04-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-04-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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) 3. 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) 4. Patients with eGFR（estimated Glomerular Filtration Rate） \<30 and patients on hemodialysis/peritoneal dialysis. 5. Patients with a history of valve replacement in the heart valves. 6. Patients who are pregnant, have childbearing potential, wish to become pregnant, or are breastfeeding. 7. Patients who have a concomitant medical illness associated with expected survival less than one year. 8. Patients who have the contraindications for aspirin. 9. Patients with a diagnosis of severe allergy to aspirin or a history of hypersensitivity. 10. Patients requiring a legally acceptable representative, patients unable to obtain written informed consent, or patients unable to understand the outline or purpose of the study. 11. Other patients for whom the principal investigator or the coinvestigator judges the participation in the study inappropriate.
Contact & Investigator
Yosuke Sawa
STUDY DIRECTOR
EPS Corporation
Frequently Asked Questions
Who can join the NCT06007222 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06007222 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06007222 currently recruiting?
Yes, NCT06007222 is actively recruiting participants. Contact the research team at sawa.yosuke872@eps.co.jp for enrollment information.
Where is the NCT06007222 trial being conducted?
This trial is being conducted at Shinjuku, Japan.
Who is sponsoring the NCT06007222 clinical trial?
NCT06007222 is sponsored by OCEAN-SHD Study Group. The principal investigator is Yosuke Sawa at EPS Corporation. The trial plans to enroll 400 participants.