Myocardial InfarctionNCT00679575
Statins and Risk of Myocardial Infarction in Real Life in France
An observational study of Myocardial Infarction, run by AstraZeneca at 56 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- How many people
- 13,171 participants
- Where
- 56 sitesFrance
- Study dates
- Mar 2007to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases : Patients recruited by a cardiologist in hospital / Referents : Patients recruited by a GP, community sample
Who may be able to join
- Patients can speak French or English
- Patients can be interviewed by telephone
- Place of usual residence in the area of recruitment
Who cannot join
- Patients refusing to participate in the study
- Patients who cannot be reached by telephone
- Previous history of myocardial infarction
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
France56 sites
Research Site
Ambilly
Research Site
Angers
Research Site
Arles
Research Site
Bagnols-sur-Cèze
Research Site
Bayonne
Research Site
Béziers
Research Site
Boulogne-sur-Mer
Research Site
Bourgoin
Research Site
Bron
Research Site
Cambo-les-Bains
Research Site
Cenon
Research Site
Châteauroux
Research Site
Clermont-Ferrand
Research Site
Colmar
Research Site
Crest
Research Site
Dijon
Research Site
Draguignan
Research Site
Eaubonne
Research Site
Firminy
Research Site
Forbach
Research Site
Fréjus
Research Site
Gleizé
Research Site
Grasse
Research Site
Guéret
Research Site
La Rochelle
Research Site
Langres
Research Site
Laon
Research Site
Le Coudray
Research Site
Le Mans
Research Site
Le Puy-en-Velay
Research Site
Mayenne
Research Site
Millau
Research Site
Montélimar
Research Site
Montfermeil
Research Site
Montpellier
Research Site
Nîmes
Research Site
Orange
Research Site
Orléans
Research Site
Paris
Research Site
Pau
Research Site
Perpignan
Research Site
Puilboreau
Research Site
Rueil-Malmaison
Research Site
Rumilly
Research Site
Saint Amand Monrond
Research Site
Saint Jean Des Verges
Research Site
Saint-Estève
Research Site
Sallanches
Research Site
Salon-de-Provence
Research Site
Sens
Research Site
Thonon-les-Bains
Research Site
Toulouse
Research Site
Tours
Research Site
Tulles
Research Site
Valence
Research Site
Villefranche-de-Rouergue
About this study
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
- Conditions
- Myocardial Infarction
- Keywords
- statins, myocardial infarction, case-referent study, France
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cases : Patients with a first myocardial infarction | |
| 2 | Referents : Patients recruited by a GP during a routine consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in 2011
Secondary outcomes (3)
Assess the interaction between statin treatment and risk factors such as cholesterol, age, gender, tobacco, alcohol, co-prescriptions, co-morbidities
Measured: in 2011
Assess the populational impact of statins usage on the risk of having a first myocardial infarction
Measured: in 2011
Assess the risk of having a first myocardial infarction according to high and low dosages of statins
Measured: in 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMar 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lucien Abenhaim, Study chair, LA-SER29, rue du Faubourg Saint-Jacques75014 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679575
- Sponsor's protocol ID
- NIS-CFR-CRE-2007/1
- Status last verified
- Dec 2010
- First submitted
- 15 May 2008
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and Risk of Myocardial Infarction in Real Life in France
- ClinicalTrials.gov ID
- NCT00679575
- Acronym / sponsor ID
- NIS-CFR-CRE-2007/1
- Conditions
- Myocardial Infarction
- Keywords
- statins, myocardial infarction, case-referent study, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,171 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cases : Patients with a first myocardial infarction |
| 2 | – | –Referents : Patients recruited by a GP during a routine consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases : Patients recruited by a cardiologist in hospital / Referents : Patients recruited by a GP, community sample
Key inclusion criteria (3 listed)
- Patients can speak French or English
- Patients can be interviewed by telephone
- Place of usual residence in the area of recruitment
Key exclusion criteria (3 listed)
- Patients refusing to participate in the study
- Patients who cannot be reached by telephone
- Previous history of myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucien Abenhaim study chair
LA-SER29, rue du Faubourg Saint-Jacques75014 Paris
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by AstraZeneca at 56 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2010.