Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation in the UK

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49469
• EU PAS number:
  EUPAS45073
• Study ID:
  49469
• Official title and acronym:
  Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation in the UK
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study aims to evaluate the incidence of stroke and other outcomes in association with direct oral anticoagulants (DOACs) as compared to each other (i.e., direct comparisons) among patients with nonvalvular atrial fibrillation (AFib) in the UK. Individual DOACs of interest include apixaban, rivaroxaban, edoxaban, and dabigatran.
• Study status:
  Planned

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned: 08/06/2021

Study start date

Planned: 01/09/2021

Date of final study report

Planned: 28/02/2022

Sources of funding

Other

More details on funding

Aetion

Study protocol

Initial protocol

AFib Protocol_07JAN22_FINAL

Regulatory

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