Status: Ongoing
First registered on:
09/03/2016
Last updated on:
01/04/2016
1. Study identification
EU PAS Register NumberEUPAS12733
Official titleRiesgo de accidente vascular cerebral asociado al uso de medicamentos: estudio de casos y controles
Study title acronymIJG-AVC-2015
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)?
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 groupMedicine research unit
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Details of (Primary) lead investigator
Title Dr
Last name Quijada Manuitt
First name Maria Angeles
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 signed02/11/201515/01/2016
Start date of data collection14/03/201614/03/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report31/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBeribérica S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Quijada Manuitt
First name Maria Angeles
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824559
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Quijada Manuitt
First name Maria Angeles
Address line 1Gran Via Corts Catalanes, 587
Address line 2
Address line 3
CityBarcelona
Postcode08007
CountrySpain
Phone number (incl. country code)34-93-4824559
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Ischaemic stroke
Haemorrhagic stroke
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 subjects132000
Additional information
12,000 cases
120,000 controls
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?
Disease epidemiology
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To assess the association between stroke and exposure to different pharmacological groups and active principles
Are there primary outcomes?Yes
Demographic and anthropometric characteristics (age, sex, geographic distribution, MEDEA index, physical activity and BMI); toxic habits (smoking, alcohol), medical history (hypertension, diabetes, cardiovascular, cerebrovascular and peripheral vascular disease, osteoarthritis, inflammatory arthritis, dementia, bipolar disorder, depression/anxiety, chronic obstructive pulmonary disease, etc.)
Are there secondary outcomes?Yes
Charlson index, frequenting primary care (number of visits in the last year) and the number of prescriptions (active on index date); laboratory parameters (lipid profile, glycaemia and glycated hemoglobin, uric acid, glomerular filtration rate [last predetermination to the index date]), cardiovascular risk assessment and drug exposure.
13. Study design
What is the design of the study?
Case-control 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
We will analyze stroke risk associated with exposure to drugs adjusted by risk factors (age, sex, and other variable tha are shown associated with the disease and possibly the exhibition of the population) by logistic regression .
We plan to conduct a subanalysis in populations with osteoarthritis and dementia.
Associations will be expressed as odds ratio estimates and confidence intervals of 95%.
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
