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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:

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
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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 :
  1. 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 :
  1. Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities [ Time Frame: in 2011 ]
  2. Assess the populational impact of statins usage on the risk of having a first myocardial infarction [ Time Frame: in 2011 ]
  3. 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


  Show 56 Study Locations
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