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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317707
First Posted: April 25, 2006
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
  Purpose

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: Quadruple (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317707


Locations
Italy
Mario Negri Institute for Pharmacological Research
Milan, Italy, 20156
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT00317707     History of Changes
Other Study ID Numbers: R&P
First Submitted: April 21, 2006
First Posted: April 25, 2006
Last Update Posted: January 18, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Cardiovascular Diseases


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