Status: Finalised First registered on: 06/06/2013
Last updated on: 06/06/2013
1. Study identification
EU PAS Register NumberEUPAS4088
Official title: Measurement of the effectiveness of statins in vAscular morbidity and mortality Reduction in the population without history of vascular disease but with intermediate risk and ankle-brachial Index < 0.9 in primAry care setting
Study title acronymMARIA study
Study typeObservational study
Brief description of the studyObjective: To evaluate the effectiveness of statin therapy to reduce the incidence of vascular disease in patients with unknown history of vascular disease with intermediate cardiovascular risk (5-15% at 10 years) and abnormal ankle-brachial index (<0.9). Design: Population matched cohort on the basis of propensity score. Data were obtained from the Information System for the Development of Primary Care Research whose primary source of data is the the electronic health records (e-CAP) of the Institut Català de la Salut. Subjects: Population from 35 to 74 years without known vascular disease and with intermediate cardiovascular risk and ankle-brachial index <0.9 (3684 subjects in exposed cohort and 7368 in unexposed cohort). The recruitment period will be guarantee at least 3 years of follow-up. Variables: New statin users are defined according to the criteria of compliance (> 80%) and persistence (> 6 months) and with no invoicing data in the six months before the entry of the cohort. Outcomes: incidence of major cardiovascular events defined as cerebrovascular disease (fatal or not), myocardial infarction (fatal or not), unstable angina, revascularization, intermittent claudication, peripheral arterial disease diagnosis or gangrene and amputation. Moreover, death from any cause will be registered. Independent variables: demographic variables, presence of risk factors, other comorbidities, complementary tests and other drug treatments. Statistical analysis: Time varying Cox regression models will be performed to estimate the incidence of outcomes of interest adjusted for the variable start of treatment and dose (time-dependent variables) and other variables associated with the occurrence of vascular events. We will also calculate estimates of risk reduction and the number needed to treat.
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 groupGirona Research Support Unit
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Ramos
First name Rafel
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 signed01/01/201001/01/2010
Start date of data collection01/04/201001/12/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201305/05/2013
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 bodyHealth Ministry100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ramos
First name Rafel
Address line 1Maluquer Salvador 11
Address line 2 
Address line 3 
CityGirona 
Postcode 
CountrySpain
Phone number (incl. country code)34972487968 
Alternative phone number 
Fax number (incl. country code) 
Email address rramos.girona.ics@gencat.cat
Public Enquiries
Title Dr 
Last name Ramos 
First name Rafel 
Address line 1Maluquer Salvador 11 
Address line 2 
Address line 3 
CityGirona 
Postcode 
CountrySpain 
Phone number (incl. country code)34972487968 
Alternative phone number 
Fax number (incl. country code) 
Email address rramos.girona.ics@gencat.cat 
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