Background
In the acute phase of cardioembolic stroke in patients with nonvalvular atrial fibrillation
(NVAF), the recurrence rate is high. Nonvitamin K antagonist oral anticoagulants may
be appropriate for prevention of early recurrence because they have a much lower risk
of hemorrhagic stroke than warfarin.
Methods
RELAXED (Recurrent Embolism Lessened by rivaroxaban, an Anti-Xa agent, of Early Dosing
for acute ischemic stroke and transient ischemic attack with atrial fibrillation)
study is an observational study designed to investigate the optimal timing to start
administration of rivaroxaban for prevention of recurrence in NVAF patients in the
acute phase of cardioembolic stroke (ClinicalTrials.gov: NCT02129920 and UMIN-clinical trials registry: UMIN000013932). It will evaluate the efficacy
and safety of rivaroxaban with regard to infarct size, timing of initiation of rivaroxaban
medication, and other patient characteristics. A total of 2000 consecutive patients
with acute ischemic stroke in the territory of the middle cerebral artery and NVAF
will be enrolled in 100 institutes throughout Japan, and they will receive rivaroxaban
within 30 days of the index stroke for secondary prevention of stroke. The infarct
size within 48 hours after stroke onset will be measured by diffusion-weighted magnetic
resonance imaging. The primary efficacy endpoint is recurrent ischemic stroke, and
the primary safety endpoint is major bleeding during the observational period of 3
months after stroke onset. The optimal timing to start treatment with rivaroxaban
during the acute stage of ischemic stroke will be determined by analysis of the correlation
between primary endpoints and the size of cerebral infarct.
Conclusions
The RELAXED observational registry study will elucidate the optimal timing of the
initiation of rivaroxaban in acute cardioembolic stroke associated with NVAF.
Key Words
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Article info
Publication history
Published online: March 14, 2016
Accepted:
January 24,
2016
Received:
September 4,
2015
Footnotes
Funding: The RELAXED study is conducted by the Japan Cardiovascular Research Foundation with funding from Bayer Yakuhin (contract No.: 017926), Ltd.
Disclosures exceed the standards set by the Japan Stroke Society: Masahiro Yasaka has received lecture fees from Nippon Boehringer Ingelheim, Bayer Yakuhin, and Bristol-Myers Squibb. Kazuo Minematsu has received none. Kazunori Toyoda has received none. Hiroshi Yamagami has received none. Shinichi Yoshimura has received none.
Takehiko Nagao, MD, has received lecture fees from Nippon Boehringer Ingelheim, Bayer Yakuhin, and Bristol-Myers Squibb. Etsuro Mori has received none.
Teruyuki Hirano has received lecture fees from Nippon Boehringer Ingelheim and Bayer Yakuhin. Toshimitsu Hamasaki has received none.
Takenori Yamaguchi has received lecture fees from Bayer Yakuhin.
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2016.01.035
Copyright
© 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.
