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Statins and Risk of Myocardial Infarction in Real Life in France

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679575
First Posted: May 19, 2008
Last Update Posted: December 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Research Site
Bayonne, France
Research Site
Beziers, France
Research Site
Boulogne sur mer, France
Research Site
Bourgoin Jallieu, France
Research Site
Bron, France
Research Site
Cambo les Bains, France
Research Site
Cenon, France
Research Site
Chateauroux, France
Research Site
Clermont Ferrand, France
Research Site
Colmar, France
Research Site
Crest, France
Research Site
Dijon, France
Research Site
Draguignan, France
Research Site
Eaubonne, France
Research Site
Firminy, France
Research Site
Forbach, France
Research Site
Frejus, France
Research Site
Gleize, France
Research Site
Grasse, France
Research Site
Gueret, France
Research Site
La Rochelle, France
Research Site
Langres, France
Research Site
Laon, France
Research Site
Le Coudray, France
Research Site
Le Mans, France
Research Site
Le Puy en Velay, France
Research Site
Mayenne, France
Research Site
Millau, France
Research Site
Montelimar, France
Research Site
Montfermeil, France
Research Site
Montpellier, France
Research Site
Nimes, France
Research Site
Orange, France
Research Site
Orleans, France
Research Site
Paris, France
Research Site
Pau, France
Research Site
Perpignan, France
Research Site
Puilboreau, France
Research Site
Rueil Malmaison, France
Research Site
Rumilly, France
Research Site
Saint Jean des Verges, France
Research Site
Sallanches, France
Research Site
Salon de provence, France
Research Site
Sens, France
Research Site
St Amand Monrond, France
Research Site
St-Esteve, France
Research Site
Thonon les Bains, France
Research Site
Toulouse, France
Research Site
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 Submitted: May 15, 2008
First Posted: May 19, 2008
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