Status: Finalised
First registered on:
21/02/2019
Last updated on:
19/12/2019
1. Study identification
EU PAS Register NumberEUPAS28224
Official titleAdherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants
Study title acronymQD versus BID DOACs
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
Department/Research group
Organisation/affiliationThe PHARMO Institute for Drug Outcomes Research
Details of (Primary) lead investigator
Title Dr
Last name Herings
First name Ron
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?3
Countries in which this study is being conducted
International study
Germany
Italy
Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/10/201817/10/2018
Start date of data collection02/01/201902/01/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report29/11/201919/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesDaiichi Sankyo Europe GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Bezemer
First name Irene
Address line 1Van Deventerlaan 30-40
Address line 2
Address line 3
CityUtrecht
Postcode
CountryNetherlands
Phone number (incl. country code)0031307440800
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Herings
First name Ron
Address line 1Van Deventerlaan 30-40
Address line 2
Address line 3
CityUtrecht
Postcode3528 AE
CountryNetherlands
Phone number (incl. country code)31307440800
Alternative phone number31307440803
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)B01AF (Direct factor Xa inhibitors)
Substance class (ATC Code)B01AE07 (dabigatran etexilate)
7. Medical conditions to be studied
Medical condition(s)Yes
Atrial fibrillation
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 subjects130000
Additional information
The estimated number of subjects is for PHARMO only, the other data bases do not have the extractions done yet.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
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?
The primary objectives of this study are to:
• determine the relationship between adherence and QD vs. BID
• determine the relationship between persistence and QD vs. BID
• determine the relationship between adherence and switchers vs. non-switchers
• determine the relationship between persistence and switchers vs. non-switchers
• compare switching patterns for QD and BID
Are there primary outcomes?Yes
Adherence and persistence
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Patients will be followed from index date until end of data collection (i.e. patient moves out of the catchment area), death or end of data availability for the database, whichever occurs first.
15. Data analysis plan
Please provide a brief summary of the analysis method
Adherence to treatment will be defined based on the proportion of days covered (PDC) during the exposure period. Persistence with treatment will be defined as the time from index date to treatment discontinuation and will be based on DOAC treatment episodes.
Switching patterns will be assessed from the day after index date until the end of follow-up based on DOAC treatment episodes. This will be defined as either the occurrence of a dosage regimen switch or a BID/QD cluster switch (i.e. to another DOAC with the same dosage regimen).
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
