Status: Finalised
First registered on:
27/03/2014
Last updated on:
27/08/2020
1. Study identification
EU PAS Register NumberEUPAS6161
Official titleA retrospective cohort study to investigate the initiation and persistence of dual antiplatelet treatment after acute coronary syndrome in a Finnish setting – THALIA
Study title acronymTHALIA
Study typeObservational study
Brief description of the studyMyocardial infarction affects about 5000 new patients in Finland every year. Approximately 20% of these patients die within one year after the event. Dual antiplatelet treatment (DAPT) with low dose acetylsalicylic acid and oral antiplatelet is recommended for patients with acute coronary syndromes. Guidelines recommend DAPT inhibition to be maintained up to over 12 months unless contraindications are present. New oral antiplatelets (OAP) have recently been introduced in the market in the Nordic countries. It is not known how the patient selection for different DAPT treatments and no-DAPT treatment happen. Neither are the persistence of OAP treatments, switch patterns between different OAP treatments, nor patient adherence to OAP treatments understood. The main objective of this study is to characterize and describe the patients treated with DAPT vs. non-DAPT treated patients, and the switch patterns and discontinuation rates of DAPT treatments. Approximately 200 000 patients discharged from Finnish hospitals following admission for unstable angina pectoris or myocardial infarction in 2009-2013 will be studied by using data from nationwide patient registers.
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 Prami
First name Tuire
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 signed23/01/2014
Start date of data collection04/08/201407/10/2014
Start date of data analysis01/05/201518/05/2015
Date of interim report, if expected
Date of final study report29/04/201615/10/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca Nordic Baltic100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Prami
First name Tuire
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358505468459
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Prami
First name Tuire
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358505468459
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)B01AC24 (ticagrelor)
Substance class (ATC Code)B01AC04 (clopidogrel)
Substance class (ATC Code)B01AC22 (prasugrel)
7. Medical conditions to be studied
Medical condition(s)Yes
Angina unstable
Acute myocardial infarction
8. Population under study
Age
Adolescents (12 - 17 years)
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 subjects190000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
Pharmacy dispensing records
Causes of Death Registry, National Prescription Register including drug purchases and reimbursement decisions, National Hospital Care Register, National register for institutionalizations (other than hospitalizations)
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 main objective of this study is to characterize and describe the patients treated with DAPT vs. non-DAPT treated patients, and the switch patterns and discontinuation rates of DAPT treatments.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
After the index date (cohort entry date) the patients will be followed-up until moving abroad, death or the end of year 2013, whichever occurs first.
15. Data analysis plan
Please provide a brief summary of the analysis method
Drug treatment patterns in the study populations will be described as:
- Proportion of patients with OAP medication.
- Proportion of patients treated with different OAPs (any OAP and specific OAPs) for 3 months, 6 months, 9 months or 12 months after index day.
- Switch patterns of OAP medication.
- Discontinuation rates and switch patterns of OAP medication within 12 months after index day.
- Medication possession rate.
The study patients will be characterized in terms of:
- Age
- Gender
- Time spent in the hospital before discharge at index date
- Prior cardiovascular history within five years before index date
- Interventions associated with the index event
- Cardiovascular morbidity during follow-up associated with prolongation, switch or discontinuation of DAPT treatment
- Major co-morbidities
- Other medications
- Type of hospital
- Calendar year
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
Prami T, Khanfir H, Hasvold P, Reissell E, Airaksinen J, Kytö V. Concomitant use of drugs known to cause interactions with oral antiplatelets—polypharmacy in acute coronary syndrome outpatients in Finland. European Journal of Clinical Pharmacology. 2020 Feb 1;76(2):257-65.https://link.springer.com/article/10.1007/s00228-019-02777-z
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
