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
  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

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
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, see Learn About Clinical Studies.

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 July 26, 2014