Status: Finalised First registered on: 16/04/2014
Last updated on: 13/10/2016
1. Study identification
EU PAS Register NumberEUPAS6355
Official titleAssessment of the effectiveness of risk minimisation measures set up for new safety information for Efient® (Prasugrel): a multinational survey among physicians to evaluate their knowledge and consideration of the new safety warning for Prasugrel in four European countries
Study title acronymH7T-MC-B021
Study typeOther: Survey
Brief description of the studyThe research question is whether the new safety information included in the risk minimisation measures (Direct Healthcare Professional Communication (DHPC), international congress and journal publication) were effective in: • educating Healthcare Professionals (HCPs) about the increased bleeding risk when pre-treating with a loading dose of Efient® (prasugrel) prior to diagnostic coronary angiography in UA/NSTEMI patients, and • influencing their consideration of this risk when prescribing a loading dose of Efient® (prasugrel).
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Massoud
First name Toussi
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
International study

France
Germany
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/12/201320/12/2013
Start date of data collection02/06/201410/06/2014
Start date of data analysis05/08/201419/08/2014
Date of interim report, if expected
Date of final study report12/12/201405/01/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company and Daiichi Sankyo Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Salinas
First name Claudia
Address line 1Eli Lilly and Company, Lilly Corporate Center
Address line 2 
Address line 3 
CityIndianapolis 
Postcode 
CountryUnited States
Phone number (incl. country code)13174339188 
Alternative phone number 
Fax number (incl. country code) 
Email address claudia.salinas@lilly.com
Public Enquiries
Title Dr 
Last name Salinas 
First name Claudia 
Address line 1Eli Lilly and Company, Lilly Corporate Center 
Address line 2 
Address line 3 
CityIndianapolis 
Postcode 
CountryUnited States 
Phone number (incl. country code)13174339188 
Alternative phone number 
Fax number (incl. country code) 
Email address claudia.salinas@lilly.com 
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