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Statins and Risk of Myocardial Infarction in Real Life in France

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00679575
First received: May 15, 2008
Last updated: December 6, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Statins and Risk of Myocardial Infarction in Real Life in France

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ]

Enrollment: 13171
Study Start Date: March 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Cases : Patients with a first myocardial infarction
2
Referents : Patients recruited by a GP during a routine consultation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679575

  Show 56 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Lucien Abenhaim LA-SER29, rue du Faubourg Saint-Jacques75014 Paris
  More Information

No publications provided

Responsible Party: Russel Esterline, AstraZeneca
ClinicalTrials.gov Identifier: NCT00679575     History of Changes
Other Study ID Numbers: NIS-CFR-CRE-2007/1
Study First Received: May 15, 2008
Last Updated: December 6, 2010
Health Authority: France: Haute Autorité de Santé Transparency Commission

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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013