check_circleStudy Completed

Non-valvular atrial fibrillation (NVAF)

Bayer Identifier:

16296

ClinicalTrials.gov Identifier:

NCT01598051

EudraCT Number:

Not Available

EU CT Number:

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

Trial purpose

The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.
A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.
This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
    - Rivaroxaban naïve patients
    - Patients 20 years old or older.
    - Patients who agree to sign the inform consent
  • - Patients who are contraindicated by product label

Trial summary

Enrollment Goal
741
Trial Dates
May 2012 - March 2017
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

  • Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    No
  • 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 6 months
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    Safety Issue:
    Yes
  • Incidence of events of stroke
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of events of non-central nervous system embolism
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Treatment satisfaction under Rivaroxaban (ACTS/TSQM)
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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