No antithrombotic therapy versus single antiplatelet therapy after percutaneous left atrial appendage closure in non-valvular atrial fibrillation: rationale and design of the multicentre, randomised, non-inferiority NAPT-LAAC trial
-VA score ≥2 and who successfully undergo LAAC are eligible for inclusion. A total of 500 patients undergoing LAAC will be randomised (1:1) to aspirin monotherapy versus non-antithrombotic therapy for the 45 days following OAC monotherapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, and clinically relevant non-fatal bleeding during a maximum of 4 years of follow-up. Major bleeding or clinically relevant non-fatal bleeding is defined as Type 2, 3, or 5 bleeding, according to the Bleeding Academic Research Consortium definition. The NAPT-LAAC trial will determine the probable non-inferiority of long-term non-antithrombotic therapy to aspirin monotherapy in patients with NVAF who undergo LAAC. (ClinicalTrials.gov: NCT07125417; jRCTs031250110).
Authors
- Takao Morikawa (ORCID: https://orcid.org/0009-0009-2971-8191)
- Atsushi Sugiura
- Tomoyuki Tani
- Daisuke Hachinohe
- Mike Saji
- Toshiaki Otsuka
- Masaki Nakashima
- Masahiko Asami
- Kentaro Hayashida
- Yohei Ohno
- Masaki Izumo
- Toru Naganuma
- Shunsuke Kubo
- Tetsuro Shimura
- Yuki Izumi
- on behalf of the OCEAN-LAAC investigators
- Yusuke Watanabe
- Gaku Nakazawa
- Shinichi Shirai
- Shinya Okazaki
- Masanori Yamamoto
- Hiroshi Ueno
Institutions
- Toho University (JP)
- Tokai University (JP)
- St. Marianna University School of Medicine (JP)
- Keio University (JP)
- Kurashiki Central Hospital (JP)
- Sapporo Higashi Tokushukai Hospital (JP)
- New Tokyo Hospital (JP)
- Sapporo Science Center (JP)
- Toyohashi Heart Center (JP)
- Sakakibara Hospital (JP)
- Mitsui Memorial Hospital (JP)
- Toyama University Hospital (JP)
- Juntendo University Hospital (JP)
- Nagoya Heart Center (JP)
- Nippon Medical School Hospital (JP)
- Gifu Heart Center (JP)
- Kokura Memorial Hospital (JP)
- Sendai Kousei Hospital (JP)
- Nippon Medical School (JP)
- Teikyo University (JP)
- Kindai University (JP)
Publication Details
- Journal
- EuroIntervention
- Published
- 2026-04-01
- DOI
- https://doi.org/10.4244/eij-d-25-01307
- Primary Topic
- Atrial Fibrillation Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 0.00