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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:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00317707
First received: April 21, 2006
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Mario Negri Institute for Pharmacological Research

Additional 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
Study First Received: April 21, 2006
Last Updated: January 17, 2012
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013