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

Phase 3

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: N-3 Polyunsaturated Fatty Acids

• Registration Number: NCT00317707
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-25
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12513

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-3 PUFA	N-3 Polyunsaturated Fatty Acids	-

Primary Outcome Measures

Name	Time	Method
cardiovascular deaths and hospitalization for cardiovascular causes	5 years

Trial Locations

Locations (1)

Mario Negri Institute for Pharmacological Research; 🇮🇹 Milan, Italy