Design and rationale of the STroke secondary prevention with catheter ABLation and EDoxaban clinical trial in patients with non-valvular atrial fibrillation: The STABLED study
Yuki Sakamoto, Yasuhiro Nishiyama, Yu-Ki Iwasaki, Hiroyuki Daida, Kazunori Toyoda, Kazuo Kitagawa, Ken Okumura, Kengo Kusano, Nobuhisa Hagiwara, Shigeru Fujimoto, Susumu Miyamoto, Toshiaki Otsuka, Yasuyuki Iguchi, Takuya Kanamaru, Teppei Yamamoto, Jumpei Kaburagi, Tetsuya Kimura, Takuyuki Matsumoto, Kazumi Kimura, Wataru Shimizu, STABLED Study Investigators, Yuki Sakamoto, Yasuhiro Nishiyama, Yu-Ki Iwasaki, Hiroyuki Daida, Kazunori Toyoda, Kazuo Kitagawa, Ken Okumura, Kengo Kusano, Nobuhisa Hagiwara, Shigeru Fujimoto, Susumu Miyamoto, Toshiaki Otsuka, Yasuyuki Iguchi, Takuya Kanamaru, Teppei Yamamoto, Jumpei Kaburagi, Tetsuya Kimura, Takuyuki Matsumoto, Kazumi Kimura, Wataru Shimizu, STABLED Study Investigators
Abstract
Background: Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies. However, the risks and benefits of CA have not been well elucidated in patients with NVAF and who have suffered a recent ischemic stroke in prospective randomized trials. Thus, the aim of the STABLED clinical trial is to investigate the efficacy and safety of CA with anticoagulant therapy using edoxaban in patients with NVAF and a history of recent ischemic stroke.
Methods and design: The STABLED trial is a multicenter, prospective, randomized, open-label, standard medication-controlled study in Japan. The target patient number is 250, comprising 125 patients receiving standard medication and 125 receiving CA. For patients allocated to the CA group, ablation is to be performed between 1 to 6 months from the onset of index stroke. The observation period will be 3 years from the day of random allocation of the final patient to any of the groups. The primary outcome measure is the composite of recurrence of ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure.
Conclusion: This study will investigate the effectiveness and safety of CA and basic anticoagulation treatment with edoxaban for patients with NVAF who have suffered a recent ischemic stroke. The aim is to determine the best evidence for an optimal treatment strategy for patients with NVAF and recent stroke.
Trial registration: UMIN000031424/NCT03777631.
Keywords: Anticoagulation treatment; Catheter ablation; Edoxaban; Ischemic stroke; Non-valvular ischemic stroke.
Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Source: PubMed