Xarelto [SPAF] Post-marketing Surveillance in Japan

• ClinicalTrials.gov Identifier: NCT01582737
• Recruitment Status: Completed
• First Posted: April 23, 2012
• Last Update Posted: December 30, 2020
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Brain Ischemia	Drug: Rivaroxaban(Xarelto, BAY59-7939)

Study Design

• Study Type: Observational
• Actual Enrollment: 11310 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation of Xarelto [SPAF]
• Actual Study Start Date: May 30, 2012
• Actual Primary Completion Date: March 31, 2019
• Actual Study Completion Date: January 17, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
2. Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]
3. Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey [ Time Frame: Baseline ]

Eligibility Criteria

• Ages Eligible for Study: 0 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Criteria

Inclusion Criteria:

• PPatients 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

Contacts and Locations

Locations

Japan

Multiple Locations, Japan

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer products 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01582737
• Other Study ID Numbers: 15798; XAR-SPAF ( Other Identifier: company internal )
• First Posted: April 23, 2012
• Last Update Posted: December 30, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Xarelto; SPAF

Additional relevant MeSH terms:

Brain Ischemia; Ischemia; Pathologic Processes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants