A pharmacoepidemiological study on the risk of bleeding in new users of low-dose aspirin (ASA) in The Health Improvement Network (THIN), UK (EPISAT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45784
• EU PAS number:
  EUPAS10837
• Study ID:
  45784
• Official title and acronym:
  A pharmacoepidemiological study on the risk of bleeding in new users of low-dose aspirin (ASA) in The Health Improvement Network (THIN), UK (EPISAT)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice. These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit–risk assessment regarding major bleeding consequences of ASA exposure in general population.
• Study status:
  Finalised

Research institution and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Planned: 10/08/2015

Actual: 10/08/2015

Study start date

Planned: 01/09/2015

Actual: 01/09/2015

Date of final study report

Planned: 15/04/2017

Actual: 31/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Study protocol

Initial protocol

Study 18116_Protocol_ OS EPISAT_PASS_10-Aug-2015

Regulatory

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