Xarelto [SPAF] Post-marketing Surveillance in Japan

Completed

• Conditions: Brain Ischemia
• Interventions: Drug: Rivaroxaban(Xarelto, BAY59-7939)

• Registration Number: NCT01582737
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Study Start: 2012-05-30
• Primary Completion: 2019-03-31
• Study Completion: 2020-01-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11310

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

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Rivaroxaban(Xarelto, BAY59-7939)	Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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