Association between use of direct oral anticoagulants (DOACs) and increased risk of interstitial lung disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000133
• EU PAS number:
  EUPAS1000000133
• Study ID:
  1000000133
• Official title and acronym:
  Association between use of direct oral anticoagulants (DOACs) and increased risk of interstitial lung disease
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  New user active comparator cohort study examining the association between direct oral anticoagulant (DOAC) use and incidence of ILD compared to users of vitamin K antagonists among people with atrial fibrillation and venous thromboembolism.
• Study status:
  Planned

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 24/03/2023

Study start date

Planned: 24/03/2023

Date of final study report

Planned: 01/03/2024

Sources of funding

EMA

More details on funding

EMA in house resources

Study protocol

Initial protocol

PROTOCOL-DOAC-ILD.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable