check_circleStudy Completed
Atrial fibrillation
Bayer Identifier:
16851
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Belgian real life non-interventional study (NIS) on Xarelto in non-valvular Atrial Fibrillation (AF) patients treated for the prevention of stroke and systemic embolism
Trial purpose
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
106Trial Dates
July 2013 - December 2014Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Belgium |
Primary Outcome
- Number of patients with major bleedingsdate_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Number of patients with symptomatic thromboembolic eventsdate_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- All-cause mortalitydate_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Adverse eventsdate_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionYesSafety Issue:
- Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)date_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionNoSafety Issue:
- Quantities of resource use consumptiondate_rangeTime Frame:1 year or 30 days after end of rivaroxabanenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A