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Completed

NCT Number: NCT01582737

Xarelto [SPAF] Post-marketing Surveillance in Japan

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.

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Key information

Conditions

Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban(Xarelto, BAY59-7939)

Drug

Patients treated with Xarelto under practical manner

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Special Drug Use Investigation of Xarelto [SPAF]

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Apr 23, 2012
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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