Status: Finalised
First registered on:
23/05/2016
Last updated on:
16/01/2020
1. Study identification
EU PAS Register NumberEUPAS13470
Official titleBeyond Pooled –Part of the BEYOND study program (BEnefit of NOACs studY of nOn-valvular AF patieNts in NorDic countries)
Study title acronymBEYOND Pooled (Denmark, Norway, Sweden)
Study typeObservational study
Brief description of the studyThe overall aim of this study is to evaluate effectiveness and safety of each NOAC compared with warfarin in treatment-naïve initiators of anticoagulants with NVAF in routine clinical practice in Denmark, Norway and Sweden. The study will use pooled data from nationwide registries in Denmark, Norway and Sweden.
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 applicableCCTR protocol number: B0661103
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupAarhus University, Department of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Details of (Primary) lead investigator
Title Professor
Last name Ehrenstein
First name Vera
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
Department of Clinical Epidemiology, Olof Palmes Allé 43-45
Department of Global Public Health and Primary Care, Kalfarveien 31, NO-5018 Bergen, Norway
Centre for Pharmacoepidemiology, Karolinska Universitetssjukhuset Solna,
Countries in which this study is being conducted
International study
Denmark
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/12/2015
Start date of data collection01/10/201717/08/2018
Start date of data analysis22/11/201830/11/2018
Date of interim report, if expected
Date of final study report31/08/201929/07/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Jenkins
First name Aaron
Address line 1Walton Oaks, Dorking Road
Address line 2
Address line 3
CityTadworth, Surrey
PostcodeKT20 7NS
CountryUnited Kingdom
Phone number (incl. country code)441737330722
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Jenkins
First name Aaron
Address line 1Walton Oaks, Dorking Road
Address line 2
Address line 3
CityTadworth, Surrey
PostcodeKT20 7NS
CountryUnited Kingdom
Phone number (incl. country code)441737330722
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameEliquis
CountryUnited States
Substance INN(s)APIXABAN
Product NamePradaxa
CountryUnited States
Substance INN(s)DABIGATRAN
Product NameXarelto
CountryUnited States
Substance INN(s)RIVAROXABAN
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 subjects20000
Additional information
This is an estimated number as the total N is still not available.
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
11. Scope of the study
What is the scope of the study?
Risk assessment
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To evaluate effectiveness and safety of each NOAC compared with warfarin in treatment-naïve initiators of anticoagulants with NVAF in routine clinical practice in Denmark, Norway and Sweden.
Are there primary outcomes?Yes
Stroke/systemic embolism and major bleeding.
Are there secondary outcomes?Yes
Ischaemic stroke, haemorrhagic stroke, major intracranial bleeding, major gastrointestinal bleeding, acute myocardial infarction, or death of any cause; any hospitalized bleeding, and composite outcome of ischemic stroke, systemic embolism, myocardial infarction, or all-cause mortality.
13. Study design
What is the design of the study?
Cohort study
Retrospective cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
≥1
15. Data analysis plan
Please provide a brief summary of the analysis method
To compare risks of the endpoints across the study cohorts, time to event analysis will be undertaken, using Cox proportional-hazards regression, with death as competing risk for endpoints not including death. Crude and adjusted hazard ratios (HRs) and 95% confidence intervals (CI) will be estimated for initiators of each NOAC. Follow-up will end on the date of a given endpoint, date of death (for non-death endpoints), date of discontinuation of or switch from the index OAC, date of emigration, or 31 December 2016, whichever comes first. A patient will be considered on-treatment from the date of initiation of the on-study OAC and for the subsequent number of days corresponding to the number of tablets in a package for rivaroxaban (used once daily) or half the number of tablets in a package for dabigatran and apixaban (used twice daily).
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
