Status: Finalised
First registered on:
16/09/2013
Last updated on:
25/04/2017
1. Study identification
EU PAS Register NumberEUPAS4700
Official titleRisk of stroke and other cardiovascular events among warfarin-treated atrial fibrillation patients – a nationwide cohort study in Finland
Study title acronymFinWAF
Study typeObservational study
Brief description of the studyThis is a retrospective database linkage study using patient information system data from hospital laboratory databases with linkage to nationwide registers. The study population consists of all atrial fibrillation patients using warfarin with INR measurements in selected hospital district areas in Finland between 01-Jan-2007 and 31-Dec-2009. The main objective is to investigate and compare risk of stroke, systemic thromboembolism, myocardial infarction, bleeding events and mortality among atrial fibrillation patients in relation to International Normalized Ratio levels.
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/affiliationEPID Research Oy
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
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
Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/10/2012
Start date of data collection05/05/201416/05/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201531/12/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBristol-Myers Squibb100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358-50-3652990
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358-50-3652990
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)WARFARIN
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 subjects32000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prescription event monitoring
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
National Reimbursement Register, Finnish Care Register, National Causes of Death Register, Finnish Cancer Registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To investigate and compare risk of stroke, systemic thromboembolism, myocardial infarction, bleeding events and mortality among atrial fibrillation patients in relation to International Normalized Ratio levels: under 2.0, 2.0-3.0, and over 3.0.
Are there primary outcomes?Yes
Stroke; Other systemic thromboembolic events excluding stroke; Myocardial infarction; Bleeding events; Mortality (all-cause); Mortality (stroke); Mortality (myocardial infarction); Mortality (systemic thromboembolic events excluding stroke); Mortality (bleeding events)
Are there secondary outcomes?Yes
anemia and renal impairment
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
Follow-up of the patients starts on the index date, and ends on 31-Dec-2011, at time of death or at time of emigration whichever occurs first.
15. Data analysis plan
Please provide a brief summary of the analysis method
Stratified incidence rates with 95% CIs will be estimated for each endpoint within the strata of the INR levels, time in therapeutic INR range (TTR) categories, and other covariates.
The crude and adjusted hazard ratio (HR) estimates with 95% CIs and P-values will be estimated within the INR levels and TTR categories using the conventional Cox’s proportional hazards model adjusting for other covariates. For INR the category 2.0–3.0 will be used as the reference category. Similarly for TTR the category ≥ 60% of time will be used as the reference category.
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
Lehto M, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Hoti F,Lassila R, Raatikainen P. Risk Of Stroke, Bleeding And Mortality Is Strongly Associated With The Quality Of Warfarin Therapy. Results From The FinWAF Registry With 54568 Patients. American Heart Association's Scientific Session 2015, Orlando, US, 12-16 November, 2015http://www.abstractsonline.com/pp8/#!/3795/presentation/34550
Raatikainen P, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Lassila R, Lehto M. Poor Quality of Warfarin Therapy is Associated With Elevated Risk Of Myocardial Infarction in Patients With Atrial Fibrillation. Results From the FinWAF Registry With 54568 Patients. American Heart Association's Scientific Session 2015, Orlando, US, 12-16 November, 2015http://www.abstractsonline.com/pp8/#!/3795/presentation/36465
Lehto M, Niiranen J, Korhonen P, Mehtälä J, Khanfir H, Hoti F, Lassila R, Raatikainen P. Quality of warfarin therapy and risk of stroke, bleeding, and mortality among patients with atrial fibrillation: results from the nationwide FinWAF Registry. Pharmacoepidemiology and Drug Safety 2017. DOI: 10.1002/pds.4194http://onlinelibrary.wiley.com/doi/10.1002/pds.4194/abstract
19. Other relevant documents
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Submitted
Signed Code of Conduct Declaration
Submitted
Signed Checklist for Study
Protocols
Submitted
