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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: N-3 Polyunsaturated Fatty Acids
* Drug: Placebo: Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-3 PUFA<br> | Drug: N-3 Polyunsaturated Fatty Acids<br>* Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA<br>|
| Placebo Comparator: Olive oil<br> | Drug: Placebo: Olive oil<br>* Each subject assigned to the control group will receive 1 g/day capsule of olive oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular deaths and hospitalization for cardiovascular causes |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular risk, cardiovascular diseases, cardiovascular prevention, polyunsaturated fatty acids, diabetes, hypertension, hypercholesterolemia, obesity