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

This study has been completed.
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research Identifier:
First received: April 21, 2006
Last updated: January 17, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Cardiovascular Diseases
Drug: N-3 Polyunsaturated Fatty Acids
Drug: Placebo: Olive oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • cardiovascular deaths and hospitalization for cardiovascular causes [ Time Frame: 5 years ]

Enrollment: 12513
Study Start Date: February 2004
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-3 PUFA Drug: N-3 Polyunsaturated Fatty Acids
Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
Placebo Comparator: Olive oil Drug: Placebo: Olive oil
Each subject assigned to the control group will receive 1 g/day capsule of olive oil.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00317707

Mario Negri Institute for Pharmacological Research
Milan, Italy, 20156
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Study Chair: Tombesi Massimo, MD Centro Studi e Ricerca in Medicina Generale, Monza, Italy
Study Chair: Tognoni Gianni, MD Mario Negri Institute for Pharmacological Research, Milan, Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT00317707     History of Changes
Other Study ID Numbers: R&P
Study First Received: April 21, 2006
Last Updated: January 17, 2012

Keywords provided by Mario Negri Institute for Pharmacological Research:
cardiovascular risk
cardiovascular diseases
cardiovascular prevention
polyunsaturated fatty acids

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on May 25, 2017