Status: Finalised First registered on: 02/09/2015
Last updated on: 11/04/2018
1. Study identification
EU PAS Register NumberEUPAS10837
Official titleA pharmacoepidemiological study on the risk of bleeding in new users of low-dose aspirin (ASA) in The Health Improvement Network (THIN) UK
Study title acronymEPISAT
Study typeObservational study
Brief description of the studyTo 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name García Rodríguez
First name Luis Alberto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/08/201510/08/2015
Start date of data collection01/09/201501/09/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report15/04/201731/03/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer Pharma AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name García Rodríguez
First name Luis Alberto
Address line 1Almirante 28
Address line 2 
Address line 3 
CityMadrid 
Postcode28004 
CountrySpain
Phone number (incl. country code)34915313404 
Alternative phone number 
Fax number (incl. country code)34915312871 
Email address Clinical-Trial-Disclosure@bayer.com
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials Contact 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address Clinical-Trial-Disclosure@bayer.com 
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