A retrospective nationwide register study to characterize and compare non-valvular atrial fibrillation (NVAF) patients in Norway treated with novel oral anticoagulants (NOACs) and warfarin on drug utilization patterns, discontinuation and bleeding complication rates (Beyond Study Norway)

Study identification

• EU PAS number:
  EUPAS8611
• Study ID:
  8612
• Official title and acronym:
  A retrospective nationwide register study to characterize and compare non-valvular atrial fibrillation (NVAF) patients in Norway treated with novel oral anticoagulants (NOACs) and warfarin on drug utilization patterns, discontinuation and bleeding complication rates (Beyond Study Norway)
• DARWIN EU® study:
  No
• Study countries:
  Norway
• Study description:
  The study aims to describe the drug utilization patterns and characteristics of patients on oral anticoagulant therapy (OAC) and to describe and compare the discontinuation rates and the risk of bleeding complications between different OAC therapies. The study will be undertaken on nation-wide registries in Norway during the early post-marketing period of the novel oral anticoagulants. The study will be undertaken in Norway and will include all adult patients with NVAF and a prescription dispensed on either a NOAC or warfarin in the study period (01 January 2013 to end of September 2014 depending on data availability).
• Study status:
  Planned

Research institutions and networks

Institutions

Lifandis

Study timelines

Date when funding contract was signed

Planned:06/11/2014

Study start date

Planned:01/05/2015

Data analysis start date

Planned:01/09/2015

Date of interim report, if expected

Planned:15/10/2015

Date of final study report

Planned:30/11/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.

Regulatory

• Was the study required by a regulatory body?:
  No