Design and baseline characteristics of the Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

Background The phase III Japanese Rivaroxaban Once‐Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (J‐ROCKET AF) showed that the rivaroxaban group had a lower event rate of intracranial bleeding than the war...

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Bibliographic Details
Published in:Journal of arrhythmia 2018-04, Vol.34 (2), p.167-175
Main Authors: Ogawa, Satoshi, Minematsu, Kazuo, Ikeda, Takanori, Kitazono, Takanari, Nakagawara, Jyoji, Miyamoto, Susumu, Murakawa, Yuji, Ohashi, Yohei, Takeichi, Makiko, Okayama, Yutaka, Yamanaka, Satoshi, Inuyama, Lyo
Format: Article
Language:English
Subjects:
Age
Anticoagulants
Anticoagulants (Medicine)
Atrial fibrillation
Cardiac arrhythmia
Clinical medicine
Comparative analysis
Diabetes
Drug dosages
Embolisms
Heart attacks
Heart failure
Hypertension
Medical research
Medicine, Experimental
Nervous system
Original
Patients
postmarketing surveillance
Prevention
Regulatory approval
rivaroxaban
Safety and security measures
Stroke
Stroke (Disease)
stroke prevention
Surveillance
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Summary:Background The phase III Japanese Rivaroxaban Once‐Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (J‐ROCKET AF) showed that the rivaroxaban group had a lower event rate of intracranial bleeding than the warfarin group and that rivaroxaban was noninferior to warfarin for the principal safety outcome. However, safety and effectiveness data from unselected patients with AF in everyday clinical practice in Japan are lacking. Methods The Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a real‐world, prospective, single‐arm, observational study mandated by the Japanese authority as postmarketing surveillance. XAPASS involves patients with nonvalvular AF prescribed rivaroxaban. The principal safety outcome is a composite of major and nonmajor bleeding events, and the primary effectiveness outcome is the incidence of ischemic stroke, hemorrhagic stroke, noncentral nervous system systemic embolism, and myocardial infarction. Results In total, 11 308 patients were enrolled from April 2012 to June 2014. Their age was 73.1 ± 9.9 years, and their CHADS2 score was 2.2 ± 1.3. Female patients, patients aged ≥75 years, patients with a body weight of ≤50 kg, and patients with a creatinine clearance of
ISSN:1880-4276
1883-2148
DOI:10.1002/joa3.12034