Statins and Risk of Myocardial Infarction in Real Life in France

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ClinicalTrials.gov Identifier: NCT00679575

Recruitment Status : Completed

First Posted : May 19, 2008

Last Update Posted : December 8, 2010

Sponsor:

Information provided by:

AstraZeneca

Study Description

Brief Summary:

The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

Condition or disease
Myocardial Infarction

Study Design


Study Type :	Observational
Actual Enrollment :	13171 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Statins and Risk of Myocardial Infarction in Real Life in France
Study Start Date :	March 2007
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Medicines Heart Attack Statins

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1 Cases : Patients with a first myocardial infarction
2 Referents : Patients recruited by a GP during a routine consultation

Outcome Measures

Primary Outcome Measures :

Assess the impact of the different statins (molecules) usage on the risk of having a first myocardial infarction in a real life situation in France [ Time Frame: in 2011 ]

Secondary Outcome Measures :

Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities [ Time Frame: in 2011 ]
Assess the populational impact of statins usage on the risk of having a first myocardial infarction [ Time Frame: in 2011 ]
Assess the risk of having a first myocardial infarction according to high and low dosages of statins [ Time Frame: in 2011 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Cases : Patients recruited by a cardiologist in hospital / Referents : Patients recruited by a GP, community sample

Criteria

Inclusion Criteria:

Patients can speak French or English
Patients can be interviewed by telephone
Place of usual residence in the area of recruitment

Exclusion Criteria:

Patients refusing to participate in the study
Patients who cannot be reached by telephone
Previous history of myocardial infarction

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679575

Hide Study Locations

Locations


France
Research Site
Ambilly, France
Research Site
Angers, France
Research Site
Arles, France
Research Site
Bagnols sur Ceze, France
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Bayonne, France
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Beziers, France
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Boulogne sur mer, France
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Bourgoin Jallieu, France
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Bron, France
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Cambo les Bains, France
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Cenon, France
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Chateauroux, France
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Clermont Ferrand, France
Research Site
Colmar, France
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Crest, France
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Dijon, France
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Draguignan, France
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Eaubonne, France
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Firminy, France
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Forbach, France
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Frejus, France
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Gleize, France
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Grasse, France
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Gueret, France
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La Rochelle, France
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Langres, France
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Laon, France
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Le Coudray, France
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Le Mans, France
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Le Puy en Velay, France
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Mayenne, France
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Millau, France
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Montelimar, France
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Montfermeil, France
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Montpellier, France
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Nimes, France
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Orange, France
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Orleans, France
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Paris, France
Research Site
Pau, France
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Perpignan, France
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Puilboreau, France
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Rueil Malmaison, France
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Rumilly, France
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Saint Jean des Verges, France
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Sallanches, France
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Salon de provence, France
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Sens, France
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St Amand Monrond, France
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St-Esteve, France
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Thonon les Bains, France
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Toulouse, France
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Tours, France
Research Site
Tulles, France
Research Site
Valence, France
Research Site
Villefranche de Rouergue, France

Sponsors and Collaborators

AstraZeneca

Investigators


Study Chair:	Lucien Abenhaim	LA-SER29, rue du Faubourg Saint-Jacques75014 Paris

More Information


Responsible Party:	Russel Esterline, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00679575 History of Changes
Other Study ID Numbers:	NIS-CFR-CRE-2007/1
First Posted:	May 19, 2008 Key Record Dates
Last Update Posted:	December 8, 2010
Last Verified:	December 2010

Keywords provided by AstraZeneca:


statins myocardial infarction case-referent study France

Additional relevant MeSH terms:


Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases	Vascular Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

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