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
Year: 2026
Type: article
Study design: Study Protocol
Abstract: -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).
Source: EuroIntervention
Authors: Toshiaki Otsuka, Masanori Yamamoto, Masahiko Asami, Toru Naganuma, Yohei Ohno, Tomoyuki Tani, Gaku Nakazawa, Masaki Izumo, Mike Saji, Daisuke Hachinohe, Hiroshi Ueno, Atsushi Sugiura, Tetsuro Shimura, Shinya Okazaki, Takao Morikawa, Yuki Izumi, Masaki Nakashima, Shunsuke Kubo, Shinichi Shirai, Yusuke Watanabe, Kentaro Hayashida, on behalf of the OCEAN-LAAC investigators
Institutions: Nippon Medical School Hospital, Nippon Medical School, Toyohashi Heart Center, Mitsui Memorial Hospital, New Tokyo Hospital, Tokai University, Kindai University Hospital, Kindai University, St. Marianna University School of Medicine, Toho University, Toyama University Hospital, University of Toyama, Nagoya Heart Center, Gifu Heart Center, Juntendo University Hospital, Sakakibara Hospital, Sendai Kousei Hospital, Kurashiki Central Hospital, Kokura Memorial Hospital, Teikyo University, Keio University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7154127309