Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
NCT ID: NCT07125417
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2025-05-29
2030-03-31
Brief Summary
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The primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation (up to a maximum follow-up of 4 years).
* Participants will be enrolled in this study until the day following the implementation of LAAC and will be randomized to the SAPT arm and NAPT arm in a 1:1 ratio.
* Participants will be observed for 4 years from the time the first subject is enrolled in this study.
* Participants will visit the hospital at 45 days, 1 year, and 2 years after enrollment, and will also be followed up by telephone, basically at the end of the observation period (up to a maximum follow-up of 4 years).
\<Study treatment duration\> In both arms, OAC monotherapy will be initiated in the first 24 hours of enrollment and continued for 45 days (allowed window period: plus 2 weeks)..
* SAPT arm will continue to receive 45 days of OAC monotherapy followed by low-dose aspirin (75～100 mg/day) as an antithrombotic agent required through the end of the study observation period.
* NAPT arm do not receive antithrombotic medication after 45 days of OAC monotherapy through the end of the study observation period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SAPT Arm (Single Antiplatelet Therapy Arm)
Single Antiplatelet Therapy or No Therapy (Control)
Monotherapy with oral anticoagulants (OAC) including direct oral anticoagulants (DOAC) and vitamin K antagonist oral anticoagulants (VKA) for 45 days after left atrial appendage closure (LAAC), followed by aspirin-directed antiplatelet monotherapy (Single Antiplatelet Therapy: SAPT) through the end of the observational period.
NAPT Arm (Non-Antithrombotic Therapy Arm)
Non-Antithrombotic Therapy
Monotherapy with OAC for 45 days after LAAC, followed by no antithrombotic therapy (Non-Antithrombotic Therapy: NAPT) from enrollment through the end of the observational period.
Interventions
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Single Antiplatelet Therapy or No Therapy (Control)
Monotherapy with oral anticoagulants (OAC) including direct oral anticoagulants (DOAC) and vitamin K antagonist oral anticoagulants (VKA) for 45 days after left atrial appendage closure (LAAC), followed by aspirin-directed antiplatelet monotherapy (Single Antiplatelet Therapy: SAPT) through the end of the observational period.
Non-Antithrombotic Therapy
Monotherapy with OAC for 45 days after LAAC, followed by no antithrombotic therapy (Non-Antithrombotic Therapy: NAPT) from enrollment through the end of the observational period.
Eligibility Criteria
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Inclusion Criteria
2. Patient has CHA2DS2-VA score of 2 or greater
3. Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.
4. Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak \[\>3 mm\] or major morbidity by the time of procedure completion).
5. Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms
6. LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure
7. The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure
8. Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study
Exclusion Criteria
2. Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis).
3. Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and/or subinvestigator judged the need for antiplatelet therapy).
4. Patients who meet one or more of the following criteria
* Patients who are contraindicated for DOAC or VKA
* Patients with a contraindication to aspirin
* Patients diagnosed with an allergy to aspirin
5. Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiac ablation, cataract surgery, other structural heart interventions).
6. Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment
7. Patients with active bleeding
8. Individuals who lack LAA or whose LAA has been surgically ligated
9. Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment
10. Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device
11. Patients with mechanical valve prostheses at any site
12. Persons with known contraindications to TEE
13. Patients with active infection
14. Individuals with NYHA class related IV congestive heart failure at enrollment
15. Patients who are pregnant, breastfeeding, or wishing to become pregnant
16. Patients with an expected life expectancy of less than 2 years
17. Patients requiring emergency surgery for any reason
18. Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol
19. Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
OCEAN-SHD Study Group
OTHER
Responsible Party
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Locations
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Nagoya Heart Center
Nagoya, Aichi-ken, Japan
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan
New Tokyo Hospital
Matsudo, Chiba, Japan
Kokura Kinen Hospital
Kitakyushu, Fukuoka, Japan
Gifu Heart Center
Gifu, Gifu, Japan
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
St.Marianna University Hospital
Kawasaki, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
IMS Tokyo Katsushika General Hospital
Katsushika-ku, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Countries
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Central Contacts
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Facility Contacts
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Atsushi Sugiura
Role: primary
Masanori Yamamoto
Role: primary
Toru Naganuma
Role: primary
Shinichi Shirai
Role: primary
Tetsuro Shimura
Role: primary
Daisuke Hachinohe
Role: primary
Tomoyuki Tani
Role: primary
Yohei Ohno
Role: primary
Masaki Izumo
Role: primary
Masaki Nakashima
Role: primary
Shunsuke Kubo
Role: primary
Takao Morikawa
Role: primary
Gaku Nakazawa
Role: primary
Shinya Okazaki
Role: primary
Masahiko Asami
Role: primary
Yuki Izumi
Role: primary
Yusuke Watanabe
Role: primary
Hirofumi Hioki
Role: primary
Mike Saji
Role: primary
Kentaro Hayashida
Role: primary
Hiroshi Ueno
Role: primary
Other Identifiers
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NAPT-LAAC trial
Identifier Type: -
Identifier Source: org_study_id
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