check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

16691

ClinicalTrials.gov Identifier:

NCT01800006

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xarelto for prevention of stroke in patients with atrial fibrillation in Latinamerica and EMEA region

Trial purpose

This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

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 systemic embolism, and who consent to participate in the study.

Trial summary

Enrollment Goal
2101
Trial Dates
January 2013 - June 2016
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, Kazakhstan
Completed
Many Locations, Russia
Completed
Many Locations, Venezuela
Completed
Many Locations, Mexico
Withdrawn
Many Locations, Peru
Completed
Many Locations, Uruguay
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Kenya
Withdrawn
Many Locations, Ecuador
Completed
Many Locations, Egypt
Completed
ManyLocations, Saudi Arabia
Completed
ManyLocations, Jordan
Completed
ManyLocations, Lebanon
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, Argentina
Completed
Many Locations, Chile
Completed
Many Locations, Bahrain
Withdrawn
Many Locations, Algeria
Completed
Many Locations, Azerbaijan
Completed
Many Locations, Colombia
Withdrawn
Many Locations, Morocco
Withdrawn
Many Locations, Kuwait
Withdrawn
Many Locations, Qatar
Completed
Many Locations, Georgia

Primary Outcome

  • Adjudicated major bleeding events
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
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    Safety Issue:
    Yes
  • Safety variables will be summarized using descriptivestatistics 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
    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
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Reasons for switch of rivaroxaban treatment
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
  • Reasons for interruption of rivaroxaban treatment
    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 therapy
    date_rangeTime Frame:
    after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later

Trial design

XANTUS-EL, Xarelto® on prevention of stroke and noncentral nervous system systemic embolism in patients with non-valvular atrial fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): 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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