Status: Finalised
First registered on:
11/12/2014
Last updated on:
27/08/2020
1. Study identification
EU PAS Register NumberEUPAS8205
Official titleRisk of subsequent cardiovascular events in patients discharged after myocardial infarction - Perseus
Study title acronymPERSEUS
Study typeObservational study
Brief description of the studyMyocardial infarction affects about 5000 patients in Finland per year. Almost 20% of them die within one year after the event. Among the Nordic countries, cardiovascular death rates are the highest in Finland. Current guidelines advise to treat myocardial infarction patients with 12-month dual antiplatelet treatment. An ongoing PEGASUS-TIMI 54 clinical study aims to survey the advantages of longer use of ticagrelor and acetylsalicylic acid in secondary prevention.
The aim of the present study is to describe the risk development and risk factors of subsequent cardiovascular events in patients discharged from hospital after myocardial infarction. The study questions focus on patients surviving more than one year without subsequent myocardial infarction or stroke and on patients with known additional risk factors. Pre-specified subgroup analyses in populations mimicking the PEGASUS-TIMI 54 study population in a real-life setting will be performed to enable comparison of real-life and randomised study settings.
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 applicableAstra Zeneca: D1843R00244; EPID Research: ER-9502
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 signed04/11/2014
Start date of data collection01/09/201512/08/2015
Start date of data analysis01/09/201515/10/2015
Date of interim report, if expected
Date of final study report30/06/201617/05/2016
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)358-50-5468459
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)358-50-5468459
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
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 subjects44000
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?
Disease epidemiology
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
The main objective is to describe the risk development and risk factors of subsequent cardiovascular events in patients discharged from hospital after myocardial infarction. We study all patients alive one week after the discharge, and because the mortality is high during the first year, the main focus is in patients surviving without subsequent myocardial infarction or stroke more than one year.
Are there primary outcomes?Yes
Myocardial infarction (ICD-10 I21-I22), Stroke (total) (ICD-10 I61-64), Cardiovascular mortality (death due to ICD-10 I21-I22, I61-64, I50, I48, I20.0), Composite end-point (deaths due to MI, stroke or cardiovascular mortality causes specified above), Overall mortality (death from any cause)
Are there secondary outcomes?Yes
Heart failure (ICD-10 I50), Atrial fibrillation (ICD-10 I48), Unstable angina pectoris (ICD-10 I20.0), Major bleedings (ICD-10 D62, D68.3, I60, J94.2, K22.1, K22.3, K22.6, K25.0, K25.2, K25.4, K25.6, K26.0, K26.2, K26.4, K26.6, K27.0, K27.4, K27.6, K28.0, K28.2, K28.4, K28.6, K29.0, K62.5, K63.1, K63.3, K92.0-K92.2, R04, R31, S06.4-S06.6)
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
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
R language will be used for in data management for creating the analysis database and in statistical analysis for creating tabulations and graphics as well as in all statistical modelling. If a variable is totally missing it is excluded from the analysis. If a variable is missing for only some of the patients a missing data category is added and used in the analysis. The principles of the statistical analysis by objectives are outlined in protocol. More detailed statistical analysis plans will be written separately.
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
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
