Trial | NCT00317707  Report issue

Title

Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    12513
In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.

Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.

The Risk and Prevention study combines an epidemiological and an experimental approach in order to:

Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)
Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of cardiovascular events, through a controlled, randomised, double blind clinical trial.
Study Started
Feb 29
2004
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Jan 18
2012
Estimate

Drug N-3 Polyunsaturated Fatty Acids

Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA

Drug Placebo: Olive oil

Each subject assigned to the control group will receive 1 g/day capsule of olive oil.

N-3 PUFA Experimental

Olive oil Placebo Comparator

Criteria 

Inclusion Criteria:

Multiple risk factors:

diabetes,
age => 65 years,
male sex,
hypertension,
hypercholesterolemia,
smoking,
obesity,
family history of premature cardiovascular disease;
Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack [TIA], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)

Exclusion Criteria:

Contraindications (known allergies to n-3 PUFA) or indications (previous myocardial infarction) for the treatment with n-3 PUFA
Serious comorbidity with an unfavourable prognosis over the short term
Expected non compliance over a long period of time
Pregnancy
No Results Posted