Status: Finalised
First registered on:
08/10/2014
Last updated on:
20/09/2018
1. Study identification
EU PAS Register NumberEUPAS7591
Official titleEvaluation of potential off-label use of dabigatran etexilate in Europe
Study title acronym
Study typeObservational study
Brief description of the studyThis is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name Pladevall-Vila
First name Manel
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?4
Countries in which this study is being conducted
International study
Denmark
France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/11/2013
Start date of data collection03/11/201428/11/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/201615/12/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pladevall-Vila
First name Manel
Address line 1Trav. Gracia, 56, Atico 1
Address line 2
Address line 3
CityBarcelona
Postcode08006
CountrySpain
Phone number (incl. country code)34932417768
Alternative phone number34932417766
Fax number (incl. country code)34934142610
Public Enquiries
Title Dr
Last name Pladevall-Vila
First name Manel
Address line 1Trav. Gracia, 56, Atico 1
Address line 2
Address line 3
CityBarcelona
Postcode08006
CountrySpain
Phone number (incl. country code)34932417768
Alternative phone number34932417766
Fax number (incl. country code)34934142610
6. Study drug(s) information
Single-Constituent (Substance INN)DABIGATRAN ETEXILATE
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
9. Number of subjects
Estimated total number of subjects15000
Additional information
Approximately 5000 new users per country.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
Cegedim Strategic Data – Longitudinal Patient Database, France
The Danish National Health Registries, Denmark
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
Estimate the proportion of off-label use in new users of dabigatran according to the recorded clinical indication or generated proxies as available in each DB.
Describe the characteristics of new users of dabigatran including dose, demographics, clinical indication, morbidity and use of other medications prior to the first captured prescription, stratified by usage sub-group—on- or off-label use.
Are there primary outcomes?Yes
The main outcome of this study is the proportion of off-label use estimated among new users of dabigatran etexilate; new users will be characterised.
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional study
Drug utilisation 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
The analyses will be descriptive at baseline. The main analysis will be to estimate (with 95% confidence intervals) the prevalence proportion of off-label use among new users of dabigatran etexilate during the overall study period in each of the study populations. All the results will be presented for each country-specific database. A weighted, pooled prevalence of off-label use among new users of dabigatran etexilate for the entire study population (study populations of the CPRD, Cegedim, and Danish national databases combined) will be estimated (with 95% confidence intervals) when the individual results of all three databases are available.
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
Cainzos-Achirica M, Varas-Lorenzo C, Pottegård A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off‐label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018;27:713–723. DOI: 10.1002/pds.4416https://onlinelibrary.wiley.com/doi/abs/10.1002/pds.4416
Cainzos-Achirica M, Varas-Lorenzo C, Pottegård A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall M. Evaluation of Potential Off-Label Prescribing of Dabigatran Etexilate in France, Denmark, and the United Kingdom and Associated Methodological Challenges. Pharmacoepidemiol Drug Saf 2017; 26(Suppl 2); p566. DOI: 10.1002/pds.4275https://www.rtihs.org/publications/evaluation-potential-label-prescribing-dabigatran-etexilate-france-denmark-and-united
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
