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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2011-10-31

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:

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.

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Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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N-3 PUFA

Group Type EXPERIMENTAL

N-3 Polyunsaturated Fatty Acids

Intervention Type DRUG

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

Olive oil

Group Type PLACEBO_COMPARATOR

Placebo: Olive oil

Intervention Type DRUG

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

Interventions

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N-3 Polyunsaturated Fatty Acids

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

Intervention Type DRUG

Placebo: Olive oil

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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No