Status: Finalised
First registered on:
06/02/2018
Last updated on:
19/09/2019
1. Study identification
EU PAS Register NumberEUPAS22075
Official titleEU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care (20150333)
Study title acronym
Study typeObservational study
Brief description of the study
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 nameAmgen
Centre locationUSA
Details of (Primary) lead investigator
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?153
Countries in which this study is being conducted
International study
Austria
Belgium
Czech Republic
Denmark
France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Poland
Romania
Slovakia
Spain
Sweden
Ukraine
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/11/201617/11/2016
Start date of data collection01/06/201701/06/2017
Start date of data analysis22/02/201922/02/2019
Date of interim report, if expected
Date of final study report19/09/201916/08/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen Ltd.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2
Address line 3
CityThousand Oaks
Postcode91320-1799
CountryUnited States
Phone number (incl. country code)18054473505
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2
Address line 3
CityThousand Oaks
Postcode91320-1799
CountryUnited States
Phone number (incl. country code)18054473505
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameRepatha
CountryUnited Kingdom
Substance INN(s)EVOLOCUMAB
7. Medical conditions to be studied
Medical condition(s)Yes
Ischaemic stroke
Myocardial infarction
Peripheral vascular disorder
Hypercholesterolaemia
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects6000
Additional information
Myocardial Infarction:Peripheral Vascular Disease:Ischaemic Stroke patients = 1:2:2, with roughly 50% of patients from primary care and 50% originating from secondary care treatment centres
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
medical notes (primary and secondary care)
11. Scope of the study
What is the scope of the study?
Characterise unmet medical need
Primary scope : Characterise unmet medical need
12. Main objective(s)
What is the main objective of the study?
To estimate the proportion of subjects in EU primary and secondary care, with or without established ASCVD and receiving LMT, with LDL-C above 2016 Joint ESC Guideline recommended levels
Are there primary outcomes?Yes
LDL-C measurement most recent to enrolment
Are there secondary outcomes?Yes
Lipid levels (total cholesterol, non-HDL-C, HDL, triglycerides, Lp(a), apo B100, apo A1) most recent to enrolment; use of Lipid-modifying therapy (type, dose, frequency); clinical characteristics at time of enrolment
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
All summaries of data will be descriptive in nature: categorical variables in frequency and percentage with 95% confidence intervals and continuous variables in mean (standard deviation) and/or median with percentiles, minimum and maximum.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
