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Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Sponsor: OCEAN-SHD Study Group
Summary
The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk. 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.
Official title: Non-Antithrombotic Versus. Single antiPlatelet Therapy Following Left Atrial Appendage Closure:NAPT-LAAC Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-05-29
Completion Date
2030-03-31
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (21)
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