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

Sponsored by:	Mario Negri Institute for Pharmacological Research
Information provided by:	Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:	NCT00317707

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:

Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)
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: polyunsaturated fatty acids (n-3 PUFA)	Phase III

Genetics Home Reference related topics: hypercholesterolemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	12000
Study Start Date:	February 2004
Estimated Study Completion Date:	February 2011

Intervention Details:

1 g/day n-PUFA

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

Responsible Party:	Mario Negri Institute for Pharmacological Research ( Tombesi Massimo, MD. Tognoni Gianni MD )
Study ID Numbers:	R&P
Study First Received:	April 21, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00317707
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

Study placed in the following topic categories:

Obesity
Diabetes Mellitus
Hypercholesterolemia
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009