Real-world evidence for non-valvular atrial fibrillation patients treated with oral anticoagulation in the Nordics (REATTAIN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45933
• EU PAS number:
  EUPAS33167
• Study ID:
  45933
• Official title and acronym:
  Real-world evidence for non-valvular atrial fibrillation patients treated with oral anticoagulation in the Nordics (REATTAIN)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential for the prevention of stroke or systemic embolism (SE) in patients with atrial fibrillation. While there are significant number of real-world evidence (RWE) publications on the use of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. This study aims to assess the effectiveness and safety of these regimens compared to VKA for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). The study will evaluate patients treated in routine clinical practice across the Nordic countries.
• Study status:
  Ongoing

Research institution and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 26/07/2019

Study start date

Planned: 01/03/2020

Actual: 01/03/2020

Date of final study report

Planned: 31/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

20030_Study Protocol_V1.0_2019-08-19_redacted

Updated protocol

20030_Study Protocol_Redacted_V2.2_2020-11-26

Regulatory

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