Xarelto [SPAF] Post-marketing Surveillance in Japan

Brain Ischemia Clinical Trial

Official title:

Special Drug Use Investigation of Xarelto [SPAF]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582737
• Other study ID #: 15798
• Secondary ID: XAR-SPAF
• Status: Completed
• Start date: May 30, 2012
• Est. completion date: January 17, 2020

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11310
• Est. completion date: January 17, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Ischemia

Intervention

Drug:
• Rivaroxaban(Xarelto, BAY59-7939)
Patients treated with Xarelto under practical manner

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of events of stroke		Up to 5 years
Primary	Incidence of events of non-central nervous system embolism		Up to 5 years
Secondary	Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey		Baseline
Secondary	Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey		Baseline
Secondary	Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey		Baseline

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