Post-Authorization Safety Study (PASS): Investigating the occurrence of major bleedings in real life, in patients with atrial fibrillation (AF) treated with the combination of apixaban and dronedarone compared against patients on warfarin and dronedarone

Study identification

• EU PAS number:
  EUPAS15449
• Study ID:
  28182
• Official title and acronym:
  Post-Authorization Safety Study (PASS): Investigating the occurrence of major bleedings in real life, in patients with atrial fibrillation (AF) treated with the combination of apixaban and dronedarone compared against patients on warfarin and dronedarone
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  Apixaban is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (AF). In addition, Swedish patients with paroxysmal AF are frequently treated with dronedarone as a way to prevent the occurrence of attacks of AF. There are hospitals in Sweden using the combination of apixaban and dronedarone in patients while others have decided to continue using the older drug warfarin to prevent stroke in combination with dronedarone, until there is more data available of using apixaban in combination with dronedarone. This is a Swedish retrospective cohort study using national register linkage data. Data from three registers will be extracted and linked, a dispensed drug register, a patient register, and a cause of death register. The primary objective of this study is to compare the occurrence of major bleedings in patients with AF treated with the combination of apixaban and dronedarone versus the combination of warfarin and dronedarone. Other objectives include the occurrence of intracranial haemorrhage, gastrointestinal bleedings, and all-cause mortality.
• Study status:
  Finalised

Research institutions and networks

Institutions

Friberg Research AB, Karolinska Institute

Sweden

Study timelines

Date when funding contract was signed

Planned:01/04/2016

Actual:13/04/2016

Study start date

Planned:16/01/2017

Actual:30/03/2017

Data analysis start date

Planned:01/11/2016

Actual:30/03/2017

Date of final study report

Planned:28/02/2017

Actual:09/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable