NCT01582737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

6.8 years

First QC Date

April 20, 2012

Last Update Submit

July 20, 2023

Conditions

Brain Ischemia

Keywords

XareltoSPAF

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Group 1

Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism

Drug: Rivaroxaban(Xarelto, BAY59-7939)

Interventions

Rivaroxaban(Xarelto, BAY59-7939)DRUG

Patients treated with Xarelto under practical manner

Group 1

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are contraindicated based on the product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (5)

  • 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.

    PMID: 31578012DERIVED

  • 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.

    PMID: 31432451DERIVED

  • 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.

    PMID: 31371191DERIVED

  • 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.

    PMID: 30745002DERIVED

  • 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.

    PMID: 29657592DERIVED

Related Links

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

May 30, 2012

Primary Completion

March 31, 2019

Study Completion

January 17, 2020

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

JP(1)