Status: Ongoing
First registered on:
29/05/2019
Last updated on:
12/06/2020
1. Study identification
EU PAS Register NumberEUPAS29910
Official titleVenous Thromboembolism Treatment
Study title acronymVOLT
Study typeObservational study
Brief description of the studyA retrospective, observational study of patients prescribed an OAC following a VTE event after the 1 January 2013 or the marketing date of NOACs in each country, whichever occurs last, using nationwide registries from multiple Nordic countries (Sweden, Norway, and Finland).
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 applicableB0661132
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEvidera
Department/Research group
Organisation/affiliationEvidera
Details of (Primary) lead investigator
Title Dr
Last name Aaron
First name Jenkins
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
International study
Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/05/201803/05/2018
Start date of data collection01/07/201902/12/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report01/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBMS/Pfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Aaron
First name Jenkins
Address line 1Pfizer Inc
Address line 2Walton Oaks
Address line 3Dorking
CityTadworth
PostcodeKT20 7NS
CountryUnited Kingdom
Phone number (incl. country code)441737330722
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Aaron
First name Jenkins
Address line 1Pfizer Inc
Address line 2Walton Oaks
Address line 3Dorking
CityTadworth
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
CountryGermany
Substance INN(s)DABIGATRAN
Product NameXarelto
CountryUnited States
Substance INN(s)RIVAROXABAN
Product NameLixiana
CountryJapan
Substance INN(s)EDOXABAN
Single-Constituent (Substance INN)WARFARIN
7. Medical conditions to be studied
Medical condition(s)Yes
Deep vein thrombosis
Pulmonary embolism
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
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
Finnish Prescription Register [FiPD, Finland
Swedish National Patient Register (SPR, Sweden
the Norwegian Patient Registry (NPR, Norway
the Finnish Care Register for Health Care (FPR), Finland
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
Phase I involves a descriptive assessment of patient characteristics and treatment patterns in each country as well as detailed power calculations.
If the study is adequately powered for comparative analyses, it will proceed to Phase II.
Phase II involves analyses of comparative effectiveness and safety, utilising warfarin as the comparator.
Are there primary outcomes?Yes
Primary efficacy; Recurrent VTE
Primary safety; Major Bleeding
Are there secondary outcomes?Yes
Treatment interruption, Complete treatment discontinuation, Treatment switching, Treatment persistence, clinically relevant non-major bleeding (CRNM bleeding), GI bleeding, intracranial haemorrhage, other bleeding, major bleeding or CRNM bleeding
13. Study design
What is the design of the study?
This is a retrospective, observational, nationwide cohort study using administrative registry data.
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
1 year+
15. Data analysis plan
Please provide a brief summary of the analysis method
Phase I of this study would be descriptive in nature, including the number, percentage of patients who discontinue, interrupt, and switch treatment. Patient characteristics will be summarised using numbers and percentages for categorical values and descriptive statistics (mean, SD, median, minimum, maximum and IQR) for continuous. Descriptive analyses will also be performed for specific subgroups.
Phase II involves comparative safety and effectiveness analyses, which for this study includes a number of clinical endpoints (recurrent VTE, bleeding by severity (major bleeding, CRNM bleeding, composite outcome (major or CRNM bleeding) and severity and site (GI, ICH, other sites) and all-cause mortality.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
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
