check_circleStudy Completed

Brain Ischemia

Bayer Identifier:

15798

ClinicalTrials.gov Identifier:

NCT01582737

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto [SPAF] post-marketing surveillance in Japan

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • - 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

  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
11310
Trial Dates
May 2012 - January 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of events of stroke
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of events of non-central nervous system embolism
    date_rangeTime Frame:
    Up to 5 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Determination of patient’s demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Determination of patient’s medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Determination of patient’s background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special drug use investigation of Xarelto [SPAF]
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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