check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
15914
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
6784Trial Dates
June 2012 - March 2015Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Many Locations, Italy | |
Withdrawn | Many Locations, Spain | |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Withdrawn | Many Locations, Greece | |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 eventsdate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapyenhanced_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 therapyenhanced_encryptionYesSafety Issue:
Secondary Outcome
- All cause mortalitydate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapyenhanced_encryptionYesSafety Issue:
- Adjudicated symptomatic thromboembolic eventsdate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapyenhanced_encryptionYesSafety Issue:
- Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatmentdate_rangeTime Frame:after 1 year or until 30 days after end of rivaroxaban therapyenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/AAdditional Information
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