Status: Finalised
First registered on:
18/04/2016
Last updated on:
14/02/2019
1. Study identification
EU PAS Register NumberEUPAS13180
Official titleApixaban drug utilization study in Stroke prevention in atrial fibrillation (SPAF)
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 to which the investigator belongsIDIAPJGol
Department/Research group
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Details of (Primary) lead investigator
Title Dr
Last name Rosa
First name Morros Pedrós
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
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/11/201511/11/2015
Start date of data collection29/04/201601/06/2016
Start date of data analysis01/07/201605/07/2016
Date of interim report, if expected01/11/201630/11/2016
Date of final study report30/12/201608/03/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Maria
First name Giner-Soriano
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824110
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Maria
First name Giner-Soriano
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824110
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)B01A (ANTITHROMBOTIC AGENTS)
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
2000 patients treated with apixaban, 14000 with VKA (warfarina 2000, acenocumarol 12000), 4000 with dabigatran and 500 with rivaroxaban
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
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 research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.
In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.
Are there primary outcomes?Yes
To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.
Are there secondary outcomes?Yes
Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC
Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations
Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban
To analyze INR
13. Study design
What is the design of the 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 use and patterns of use of Apixaban and VKA will be summarised by the total number of users, prescriptions, and number of DDDs, and by the number of users according to daily dose and duration of use. Characteristics of users, comorbidity, comedications, use of interacting drugs will be described as number and percentage of patients with each condition. The number and percentage of all variables will be calculated by apixaban VKA, dabigatran and rivaroxaban group. In general, frequencies will be used to describe the study sample characteristics and characteristics of each category group. Chi-square tests and ANOVA will be utilized to compare categorical and continuous variables, respectively, across the category groups.
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
Ainhoa Gomez-Lumbreras, Jordi Cortes, Maria Giner-Soriano, M. Angeles Quijada-Manuitt, Rosa Morros. Characteristics of apixaban-treated patients, evaluation of the dose prescribed, and the persistence of treatment: a cohort study in Catalonia. Journal of Cardiovascular Pharmacology and Therapeutics 2018;23(6):494-501.https://journals.sagepub.com/doi/abs/10.1177/1074248418778544?journalCode=cpta
Gómez-Lumbreras A, Giner-Soriano M, Quijada-Manuitt MA, Cortés J, Morros R. Póster. Uso de anticoagulantes orales directos en atención primaria: estudio de persistencia en Cataluña. XXXVIII Congreso de la semFYC. 11/05/2018, Barcelona.
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
