A Post-marketing Retrospective nOn-interventional study using naTionwide registries and electronic medical records to investigate the real-life Effectiveness and major bleeding Complications of oral anTicoagulants in Norwegian non-valvular Atrial Fibrillation patients (PROTECT-AF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45790
• EU PAS number:
  EUPAS26001
• Study ID:
  45790
• Official title and acronym:
  A Post-marketing Retrospective nOn-interventional study using naTionwide registries and electronic medical records to investigate the real-life Effectiveness and major bleeding Complications of oral anTicoagulants in Norwegian non-valvular Atrial Fibrillation patients (PROTECT-AF)
• DARWIN EU® study:
  No
• Study countries:
  Norway
• Study description:
  A nationwide observational study investigating the effectiveness and bleeding complications of NOACs vs. VKA in non-valvular atrial fibrillation patients.
• Study status:
  Finalised

Research institution and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned: 10/09/2018

Actual: 10/09/2018

Study start date

Planned: 31/10/2018

Actual: 31/10/2018

Date of final study report

Planned: 29/02/2020

Actual: 29/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

19468_CSP_V1.0_2018-09-06_Redacted

Regulatory

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