Clinical trial NCT06007222: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Official title: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aortic Stenosis
TAVI(Transcatheter Aortic Valve Implantation)
Aspirin
DAPT(Dual Antiplatelet Therapy)
SAPT(Single Antiplatelet Therapy)
Lead sponsor: OCEAN-SHD Study Group
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Primary endpoint
timeFrame: minimum 2 years, maximum 3 years of follow-up
Secondary outcomes:
measure: Key Secondary endpoint
timeFrame: minimum 1 year, maximum 3 years of follow-up
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: EPS Corporation
name: Yosuke Sawa
role: STUDY_DIRECTOR
References: