Effectiveness and safety of non-vitamin K anticoagulants (NOACs) versus warfarin in frail patients with nonvalvular atrial fibrillation (AF): a nationwide cohort study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41003
• EU PAS number:
  EUPAS39592
• Study ID:
  41003
• Official title and acronym:
  Effectiveness and safety of non-vitamin K anticoagulants (NOACs) versus warfarin in frail patients with nonvalvular atrial fibrillation (AF): a nationwide cohort study
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Growing evidence suggests that frail patients with AF are less likely to receive adequate oral anticoagulant therapy (OAC), although frail patients present higher thrombotic risk and mortality. Part of this care gap may be explained by the scarce data on the safety and effectiveness of NOACs versus warfarin in frail AF patients. Therefore, this study aimed (1) to present population characteristics and rates of effectiveness and safety outcomes among frail patients with non-valvular AF in Denmark according to OAC treatment regimen (no OAC, warfarin, or NOAC) and (2) to investigate the comparative effectiveness and safety of NOACs (Dabigatran, Rivaroxaban, and Apixaban, as a class) versus warfarin in a Danish nationwide cohort of frail patients with non-valvular AF. Non-interventional, observational cohort studies based on secondary data collection from Danish nationwide administrative databases will be used for the investigations. The source population comprise all residents of Denmark between 2013-2018. The study population will comprise all frail patients with an inpatient or outpatient primary or secondary discharge diagnosis of non-valvular AF. Frail patients will be identified using the ICD-10 based Hospital Frailty Risk Score (HFRS).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aalborg University Hospital

Thrombosis and Drug Research Unit

Study timelines

Date when funding contract was signed

Planned: 01/02/2021

Actual: 19/04/2021

Study start date

Planned: 22/02/2021

Actual: 20/04/2021

Data analysis start date

Actual: 07/05/2021

Date of final study report

Planned: 30/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG, Berlin, Germany

Regulatory

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