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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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:

1. Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)

2. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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