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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00317707

Enrollment

12513

Registered

2006-04-25

Start date

2004-02-29

Completion date

2011-10-31

Last updated

2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

cardiovascular risk, cardiovascular diseases, cardiovascular prevention, polyunsaturated fatty acids, diabetes, hypertension, hypercholesterolemia, obesity

Brief 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.

Interventions

DRUGN-3 Polyunsaturated Fatty Acids

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

DRUGPlacebo: Olive oil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
cardiovascular deaths and hospitalization for cardiovascular causes	5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026