check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

16371

ClinicalTrials.gov Identifier:

NCT01750788

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto for prevention of stroke in patients with atrial fibrillation in Asia

Trial purpose

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.

Trial summary

Enrollment Goal
2297
Trial Dates
January 2013 - October 2015
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, Indonesia
Completed
Many Locations, Korea, Republic Of
Terminated
Many Locations, India
Completed
Many Locations, Taiwan
Completed
Many Locations, Hong Kong
Completed
Many Locations, Malaysia
Completed
Many Locations, Philippines
Completed
Many Locations, Singapore
Completed
Many Locations, Thailand
Completed
Many Locations, Vietnam
Completed
Many Locations, Pakistan

Primary Outcome

  • Adjudicated major bleeding events
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
    enhanced_encryption
    Safety Issue:
    Yes
  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
    enhanced_encryption
    Safety Issue:
    Yes
  • All cause mortality
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Secondary Outcome

  • Adjudicated symptomatic thromboembolic events
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
    enhanced_encryption
    Safety Issue:
    Yes
  • Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Healthcare resource
    Number of healthcare professional visits and hospitalizations due to anticoagulation
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Adverse events rates in the different AF risk factor categories
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Trial design

Xarelto® on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in Asia: A non-interventional study
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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