A comparison of the effectiveness and safety of direct oral anticoagulants versus warfarin in older patients with atrial fibrillation using the Clinical Practice Research Datalink

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40720
• EU PAS number:
  EUPAS40058
• Study ID:
  40720
• Official title and acronym:
  A comparison of the effectiveness and safety of direct oral anticoagulants versus warfarin in older patients with atrial fibrillation using the Clinical Practice Research Datalink
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The aims of this study are to compare direct oral anticoagulants (DOACs) with warfarin in patients aged ≥ 75 years in the United Kingdom (UK) where they are prescribed for stroke prevention in atrial fibrillation (AF): 1. To compare effectiveness and safety outcomes in patients prescribed DOACs to similar patients started on warfarin prior to DOACs being licensed for use. 2. To compare effectiveness and safety outcomes in patients prescribed DOACs to similar patients started on warfarin after the DOACs were licensed for use. 3. To establish if switching between warfarin and DOACs affects safety or effectiveness outcomes 4. To determine whether safety outcomes differ between warfarin and DOACs in advanced age, for patients with low body weight (<60kg), frailty, dementia or a history of falls
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Bath

Study timelines

Date when funding contract was signed

Actual: 18/09/2017

Study start date

Planned: 19/03/2021

Actual: 03/04/2021

Date of final study report

Planned: 31/05/2021

Sources of funding

Non-for-profit organisation (e.g. charity)

More details on funding

The Dunhill Medical Trust

Regulatory

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