check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
16371
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
2297Trial Dates
January 2013 - October 2015Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 eventsdate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapy, whichever is laterenhanced_encryptionYesSafety Issue:
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapy, whichever is laterenhanced_encryptionYesSafety Issue:
- All cause mortalitydate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Secondary Outcome
- Adjudicated symptomatic thromboembolic eventsdate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapy, whichever is laterenhanced_encryptionYesSafety Issue:
- 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 bleedingsdate_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 visitdate_rangeTime Frame: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 anticoagulationdate_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 categoriesdate_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 treatmentdate_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 studydate_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 studydate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A