Trial Condition(s):
Atrial Fibrillation
Xarelto for prevention of stroke in patients with atrial fibrillation in Asia (XANAP)
Bayer Identifier:
16371
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
: - 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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Indonesia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Malaysia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Singapore | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Thailand | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Vietnam | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Pakistan | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Adjudicated major bleeding eventsTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- All cause mortalityTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Outcome
- Adjudicated symptomatic thromboembolic eventsTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- 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 bleedingsTimeframe: 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 visitTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Healthcare resourceNumber of healthcare professional visits and hospitalizations due to anticoagulationTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
- Adverse events rates in the different AF risk factor categoriesTimeframe: 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 treatmentTimeframe: 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 studyTimeframe: 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 studyTimeframe: after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Additional Information
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