Study identification

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

Contact details

Vera Ehrenstein

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Company/Pfizer EEIG
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable