Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: the APIXAMIO study

Study identification

• EU PAS number:
  EUPAS43681
• Study ID:
  49753
• Official title and acronym:
  Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: the APIXAMIO study
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  By merging and analyzing various Swedish national registry data the present real-world study will describe the patient characteristics in patients treated with amiodarone in combination with either apixaban or warfarin, and if deemed possible after feasibility assessment, compare safety outcomes, in terms of bleeding, in these two patient cohorts.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 01/06/2021

Actual: 01/06/2021

Study start date

Planned: 26/11/2021

Actual: 26/11/2021

Data analysis start date

Planned: 25/11/2021

Actual: 15/11/2022

Date of final study report

Planned: 15/10/2023

Actual: 19/09/2023

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