---
title: "Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk"
nct_id: NCT00317707
overall_status: COMPLETED
phase: PHASE3
sponsor: Mario Negri Institute for Pharmacological Research
study_type: INTERVENTIONAL
primary_condition: Cardiovascular Diseases
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00317707.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00317707"
ct_last_update_post_date: 2012-01-18
last_seen_at: "2026-05-12T06:32:55.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk

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

**NCT ID:** [NCT00317707](https://clinicaltrials.gov/study/NCT00317707)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12513
- **Lead Sponsor:** Mario Negri Institute for Pharmacological Research
- **Conditions:** Cardiovascular Diseases
- **Start Date:** 2004-02
- **Completion Date:** 2011-10
- **CT.gov Last Update:** 2012-01-18

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **N-3 PUFA** (EXPERIMENTAL)
- **Olive oil** (PLACEBO_COMPARATOR)

## Interventions

- **N-3 Polyunsaturated Fatty Acids** (DRUG) — Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
- **Placebo: Olive oil** (DRUG) — Each subject assigned to the control group will receive 1 g/day capsule of olive oil.

## Primary Outcomes

- **cardiovascular deaths and hospitalization for cardiovascular causes** _(time frame: 5 years)_

## Locations (1)

- Mario Negri Institute for Pharmacological Research, Milan, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mario negri institute for pharmacological research|milan||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00317707.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00317707*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*