Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30580
• EU PAS number:
  EUPAS14786
• Study ID:
  30580
• Official title and acronym:
  Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Apixaban (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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Study timelines

Date when funding contract was signed

Planned: 25/08/2016

Actual: 25/08/2016

Study start date

Planned: 31/08/2016

Actual: 31/08/2016

Date of final study report

Planned: 31/08/2017

Actual: 31/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Company/Pfizer EEIG

Study protocol

Initial protocol

cv185524-prot-(pfizer-protocol-B0661073)-RED

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable