Status: Finalised First registered on: 13/06/2015
Last updated on: 15/06/2015
1. Study identification
EU PAS Register NumberEUPAS9949
Official titlePost-discharge Clinical and Economic Outcomes Among Patients with ACS Managed with PCI and treated with Prasugrel versus Ticagrelor
Study title acronymH7T-MC-B023
Study typeObservational study
Brief description of the studyRetrospective cohort study using the Prometix Lx claims database to compare clinical and economic outcomes and treatment patterns among patients treated with prasugrel and those treated with ticagrelor. The primary study population will be patients with ACS managed with PCI who have no prior TIA or stroke (that is, indicated population for treatment with prasugrel). The primary study objective is to compare NACE up to one year post-discharge from an index hospitalisation. The main study hypothesis will be to show that prasugrel is associated with non-inferior outcomes at 1 year compared to ticagrelor. Secondary endpoints include clinical and economic outcomes and treatment patterns through 30 days, 6 months, and 1 year post index hospitalization discharge. Data will be assessed before and after adjustment for baseline risk differences via propensity score matching. The overall ACS-PCI population, as well as a subgroup of the primary population aged <75 years or >75 years with diabetes or prior MI, will be assessed.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsEvidera
Department/Research groupRetrospective Observational Studies
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Molife
First name Cliff
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 States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed12/12/201312/12/2013
Start date of data collection01/05/201402/06/2014
Start date of data analysis15/05/201408/06/2014
Date of interim report, if expected01/01/201527/02/2015
Date of final study report31/03/201531/05/2015
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 Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Molife
First name Cliff
Address line 1Lilly Technology Center South
Address line 21555 S Harding St 
Address line 3 
CityIndianapolis 
Postcode46221 
CountryUnited States
Phone number (incl. country code)13172207074 
Alternative phone number 
Fax number (incl. country code)13172777444 
Email address Molife_cliff@lilly.com
Public Enquiries
Title Dr 
Last name Molife 
First name Cliff 
Address line 1Lilly Technology Center South 
Address line 21555 S Harding St 
Address line 3 
CityIndianapolis 
Postcode46221 
CountryUnited States 
Phone number (incl. country code)13172207074 
Alternative phone number 
Fax number (incl. country code)13172777444 
Email address Molife_cliff@lilly.com 
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