Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims database study in Germany (CARBOS)

Study identification

• EU PAS number:
  EUPAS11313
• Study ID:
  16728
• Official title and acronym:
  Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims database study in Germany (CARBOS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The aim of this study is to investigate whether there are differences in the occurrence of major bleeding events in patients with AF under oral anticoagulation therapies in a real-world setting. It will be investigated whether the occurrence of major bleeding events in AF patients under anticoagulant therapy differs between patients treated with VKA (e.g. Phenprocoumon) and patients treated with NOACS, Apixaban, Dabigatran or Rivaroxaban respectively.
• Study status:
  Finalised

Research institutions and networks

Institutions

Health Risk Institute

Study timelines

Date when funding contract was signed

Planned: 29/05/2015

Actual: 29/05/2015

Study start date

Planned: 16/10/2015

Actual: 16/10/2015

Data analysis start date

Planned: 12/11/2015

Actual: 19/10/2015

Date of final study report

Planned: 30/11/2016

Actual: 28/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer and Bristol-Myers Squibb

Regulatory

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