Status: Ongoing
First registered on:
09/05/2017
Last updated on:
09/10/2018
1. Study identification
EU PAS Register NumberEUPAS19017
Official titleImpact of medication adherence on mortality and cardiovascular morbidity: a population-based retrospective cohort study. IMPACT study
Study title acronymIMPACT study
Study typeObservational study
Brief description of the studyCohort study with electronic health records in Primary Healthcare in order to assess the risk of major cardiovascular events and all-cause
mortality according to the level of adherence to antiplatelet agents, betablockers,
ACEI or ARB, and statins, in a population of incident cases of CHD, defined
as patients with a first episode of acute coronary syndrome (ACS). This is a population-based retrospective cohort study of patients with a first episode of
ACS registered in CMBD-HA of the ICS from 2006 to 2015.
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 groupMedicines Research Unit
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Details of (Primary) lead investigator
Title Dr
Last name Maria
First name Giner-Soriano
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 signed30/03/201730/03/2017
Start date of data collection03/07/201702/10/2017
Start date of data analysis02/10/201708/01/2018
Date of interim report, if expected
Date of final study report31/10/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherIDIAP Jordi Gol100
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 2àtic
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 2àtic
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)B01AC (Platelet aggregation inhibitors excl. heparin)
Substance class (ATC Code)C07 (BETA BLOCKING AGENTS)
Substance class (ATC Code)C09 (AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM)
Substance class (ATC Code)C10 (LIPID MODIFYING AGENTS)
7. Medical conditions to be studied
Medical condition(s)Yes
Acute coronary syndrome
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 subjects3400
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
Effectiveness evaluation
ADHERENCE
Primary scope : ADHERENCE
12. Main objective(s)
What is the main objective of the study?
To assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD.
The outcomes which are included as components of the composite endpoint are: all-cause mortality, ACS, and ischaemic stroke.
Are there primary outcomes?Yes
To assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD.
The outcomes which are included as components of the composite endpoint are: all-cause mortality, ACS, and ischaemic stroke.
Are there secondary outcomes?Yes
Incidence of the composite endpoint. Relationship between baseline socio-demographic and clinical characteristics and adherence to drug therapy. Number of days on sickness leave due to any cause according to adherence to drug therapy. Prevalence of use of the four drugs. Posology prescribed.
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
Inclusion: 2006-2015
Follow-up: 2006-2016
15. Data analysis plan
Please provide a brief summary of the analysis method
Demographic and baseline characteristics of the participants will be described using frequencies and percentages for categorical variables and mean, standard deviation or median and interquartile range for continuous variables, as appropriate.
Bivariate analyses will be performed using the Chi-square test for categorical variables and t-Student test or Mann-Whitney U test for continuous variables, according to their distribution.
Multiple imputations by chained equations will be used to replace baseline missing values. Case-complete and imputed data results will be compared as a sensitivity analysis.
The raw and adjusted HRs for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested.
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
Giner-Soriano M, Sotorra Figuerola G, Cortés J, Pera Pujadas H, Garcia-Sangenis A, Morros R. Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study. JMIR Res Protoc 2018;7(3):e73. DOI: 10.2196/resprot.8121https://www.researchprotocols.org/2018/3/e73/
Sotorra Figuerola G, Ouchi D, Giner-Soriano M, Garcia-Sangenis A, Pera Pujadas H, Morros R. Acute coronary syndrome in Catalonia: baseline characteristics of patients from a SIDIAP cohort (IMPACT study). Basic & Clinical Pharmacology & Toxicology 2018;123(S4):1-68(CP67)https://onlinelibrary.wiley.com/doi/10.1111/bcpt.13107
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
