Study identification

PURI

https://redirect.ema.europa.eu/resource/49880

EU PAS number

EUPAS10726

Study ID

49880

Official title and acronym

Observational study of post-myocardial infarction with a long follow-up (EOLE)

DARWIN EU® study

No

Study countries

France

Study description

The EOLE study was requested by French authorities at the time of new omega-3 supplementation marketing for secondary prevention of post-myocardial infarction. The main research question is to assess the impact of recommended cardiovascular drugs (beta-blockers, acetylsalicylic acid or other antiplatelet agents, statins or other lipid lowering agent, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, and omega-3 supplementation), and dietary lifestyle guidelines in real-life to all cause mortality in secondary prevention of myocardial infarction in France after 6 years of follow-up. Hospital and non-hospital cardiologists included 5527 patients from April 2006 to June 2009. Socio-demographic data, myocardial infarction characteristics, cardiovascular risk factors, history and associated cardiovascular diseases, last lab test results, cardiovascular drugs, cardiovascular rehabilitation program, tobacco use, drugs taken, hospitalisations since myocardial infarction and vital status were collected using a medical questionnaire completed at first post-myocardial infarction consultation, and a patient self-administered questionnaire filled out at inclusion, 6 month, 2, 3, 4, 5 and 6 years. At 6 years follow-up, the vital status of all patients will be ascertained from the national death registry using a standard approved national procedure whereby the national identification database is searched (decree #98-37 of 16 January 1998, modified procedure INSEE/INSERM), and failing that, through patient/relatives/physicians. An interim analysis will be planned after 3.5 years of follow-up

Study status

Finalised
Research institution and networks

Institutions

Contact details

Nicholas Moore

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pierre Fabre Médicament
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable