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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00679575
Other study ID # NIS-CFR-CRE-2007/1
Secondary ID
Status Completed
Phase N/A
First received May 15, 2008
Last updated December 6, 2010
Start date March 2007
Est. completion date November 2010

Study information

Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority France: Haute Autorité de Santé Transparency Commission
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 13171
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 in 2011
Secondary Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities in 2011
Secondary Assess the populational impact of statins usage on the risk of having a first myocardial infarction in 2011
Secondary Assess the risk of having a first myocardial infarction according to high and low dosages of statins in 2011
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