Status: Finalised First registered on: 16/08/2016
Last updated on: 19/07/2019
1. Study identification
EU PAS Register NumberEUPAS14786
Official titlePost-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark
Study title acronym
Study typeObservational study
Brief description of the studyApixaban (ELIQUIS®) is an orally administered anticoagulant that was approved in the European Union (EU) in May 2011 for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. Subsequently, apixaban received approvals for stroke and systemic embolism (SE) prevention in those with nonvalvular atrial fibrillation (NVAF), and for the treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults. This study aims to estimate the proportion of apixaban users in the outpatient settings who receive the drug for the approved indications at the time of the study, and describe the characteristics of the patients who are prescribed apixaban for on-label and off-label indications. These aims will be examined with a descriptive, retrospective, cross-sectional study that uses electronic healthcare data from the Danish national registries. All patients dispensed apixaban as recorded in the Danish Health Services Prescription Database from May 2011 to December 2014 will be included.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Dr
Last name Ehrenstein
First name Vera
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/08/201625/08/2016
Start date of data collection31/08/201631/08/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/08/201731/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBristol-Myers Squibb Company/Pfizer EEIG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schachterle
First name Stephen
Address line 1219 East 42nd Street
Address line 2 
Address line 3 
CityNew York City, NY 
Postcode10017 
CountryUnited States
Phone number (incl. country code)012127339192 
Alternative phone number 
Fax number (incl. country code) 
Email address Stephen.Schachterle@pfizer.com
Public Enquiries
Title Dr 
Last name Schachterle 
First name Stephen 
Address line 1219 East 42nd Street 
Address line 2 
Address line 3 
CityNew York City, NY 
Postcode10017 
CountryUnited States 
Phone number (incl. country code)0112127339192 
Alternative phone number 
Fax number (incl. country code) 
Email address Stephen.Schachterle@pfizer.com 
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