check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

15914

ClinicalTrials.gov Identifier:

NCT01606995

EudraCT Number:

Not Available

EU CT Number:

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

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
6784
Trial Dates
June 2012 - March 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Completed
Many Locations, Poland
Withdrawn
Many Locations, Italy
Withdrawn
Many Locations, Spain
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Sweden
Completed
Many Locations, Denmark
Completed
Many Locations, Norway
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Austria
Completed
Many Locations, Hungary
Withdrawn
Many Locations, Greece
Completed
Many Locations, Russia
Completed
Many Locations, Slovakia
Completed
Many Locations, Ukraine
Completed
Many Locations, Slovenia
Completed
Many Locations, Ireland
Completed
Many Locations, Moldova
Completed
Many Locations, Canada

Primary Outcome

  • Adjudicated major bleeding events
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy
    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
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • All cause mortality
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • Adjudicated symptomatic thromboembolic events
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy
    enhanced_encryption
    Safety Issue:
    Yes
  • Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy
    enhanced_encryption
    Safety Issue:
    No

Trial design

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