Condition: Nonvalvular Atrial Fibrillation · Aspirin · Non-Antithrombotic Therapy · Sponsor: OCEAN-SHD Study Group
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…
This description comes directly from the study's public registry record.
EPS Corporation · +81-6-7176-5731 · prj-laac-napt@eps.co.jp
Always discuss trial participation with your own doctor first.
| Nagoya Heart Center | Nagoya, Aichi-ken, Japan | Recruiting |
| Toyohashi Heart Center | Toyohashi, Aichi-ken, Japan | Recruiting |
| New Tokyo Hospital | Matsudo, Chiba, Japan | Recruiting |
| Kokura Kinen Hospital | Kitakyushu, Fukuoka, Japan | Recruiting |
| Gifu Heart Center | Gifu, Gifu, Japan | Recruiting |
| Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic | Sapporo, Hokkaido, Japan | Recruiting |
| Sapporo Higashi Tokushukai Hospital | Sapporo, Hokkaido, Japan | Recruiting |
| Tokai University Hospital | Isehara, Kanagawa, Japan | Recruiting |
| St.Marianna University Hospital | Kawasaki, Kanagawa, Japan | Recruiting |
| Sendai Kousei Hospital | Sendai, Miyagi, Japan | Recruiting |
| Kurashiki Central Hospital | Kurashiki, Okayama-ken, Japan | Recruiting |
| The Sakakibara Heart Institute of Okayama | Okayama, Okayama-ken, Japan | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07125417