Xarelto [SPAF] Post-marketing Surveillance in Japan

Special Drug Use Investigation of Xarelto [SPAF]

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.

The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.

A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Study Overview

• Status: Completed
• Conditions: Brain Ischemia
• Intervention / Treatment: Drug: Rivaroxaban(Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 11310

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular arterial fibrillation necessary for the treatment for prevention of ischemic stroke and systemic embolism

Description

Inclusion Criteria:

• Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made
• Patients without experience of using Xarelto prior to the study

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism	Drug: Rivaroxaban(Xarelto, BAY59-7939); Patients treated with Xarelto under practical manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)	Up to 2 years
Incidence of events of stroke	Up to 5 years
Incidence of events of non-central nervous system embolism	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline
Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline
Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey	Baseline

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

General Publications

• Minematsu K, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-World Outcomes of Rivaroxaban Treatment in Patients with Both Nonvalvular Atrial Fibrillation and a History of Ischemic Stroke/Transient Ischemic Attack. Cerebrovasc Dis. 2019;48(1-2):53-60. doi: 10.1159/000502883. Epub 2019 Oct 2.
• Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Iwashiro S, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings. J Thromb Thrombolysis. 2019 Nov;48(4):653-660. doi: 10.1007/s11239-019-01934-6.
• Nakagawara J, Ikeda T, Ogawa S, Kitazono T, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function. J Cardiol. 2019 Dec;74(6):501-506. doi: 10.1016/j.jjcc.2019.06.003. Epub 2019 Jul 29.
• Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Ohashi Y, Okayama Y, Sunaya T, Yamanaka S. Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Cardiol. 2019 Jul;74(1):60-66. doi: 10.1016/j.jjcc.2019.01.001. Epub 2019 Feb 8.
• Ogawa S, Minematsu K, Ikeda T, Kitazono T, Nakagawara J, Miyamoto S, Murakawa Y, Ohashi Y, Takeichi M, Okayama Y, Yamanaka S, Inuyama L. Design and baseline characteristics of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS). J Arrhythm. 2018 Feb 7;34(2):167-175. doi: 10.1002/joa3.12034. eCollection 2018 Apr.

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2012
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (Estimated): April 23, 2012

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Xarelto; SPAF
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 15798; XAR-SPAF (Other Identifier: company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No