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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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.
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.
Nagoya Heart Center
Nagoya, Aichi-ken, Japan
RECRUITINGToyohashi Heart Center
Toyohashi, Aichi-ken, Japan
RECRUITINGNew Tokyo Hospital
Matsudo, Chiba, Japan
RECRUITINGKokura Kinen Hospital
Kitakyushu, Fukuoka, Japan
RECRUITINGGifu Heart Center
Gifu, Gifu, Japan
RECRUITINGMedical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, Japan
RECRUITINGSapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
RECRUITINGTokai University Hospital
Isehara, Kanagawa, Japan
RECRUITINGSt.Marianna University Hospital
Kawasaki, Kanagawa, Japan
RECRUITINGSendai Kousei Hospital
Sendai, Miyagi, Japan
RECRUITING...and 11 more locations
A composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding
The definition of major bleeding or clinically significant nonfatal bleeding for the primary endpoint is BARC type 2, 3, or 5 bleeding among BARC type 1, 2, 3, 4, and 5. Surviving cases with no events shall be censored as of the date of discontinuation of study treatment or the date of last confirmation of survival. Planned enrollment term is two years, and all subjects will be obsserved until 4 years after first enrollment.
Time frame: Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.
Non-procedure-related BARC bleeding events of Type 1 or greater
Non-procedure-related was defined as occurring after 7 days after the LAAC procedure. It will be assessed throughout the entire study period, as well as from the day following Visit 1 (occurring 46 to 60 days post-randomization) until the end of the study.
Time frame: Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.
ISTH major bleeding not related to the procedure and clinically relevant non-fatal bleeding
Not related to the procedure refers to events occurring 7 days after the LAAC procedure. It will be assessed throughout the entire study period, as well as from the day following Visit 1 (occurring 46 to 60 days post-randomization) until the end of the study.
Time frame: Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.
Incidence of device-related thrombus (DRT) detected by CT and/or transesophageal echocardiography (TEE)
Time frame: at Visit 1 (46~60days after randomization), 1 year, and 2 years after randomization
Combined endpoint consisting of the occurrence of ischemic stroke and systemic embolism
It will be assessed throughout the entire study period, as well as from the day following Visit 1 (occurring 46 to 60 days post-randomization) until the end of the study.
Time frame: Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.
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