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

Mario Negri Institute for Pharmacological Research1 site in 1 country12,513 target enrollmentFebruary 2004

ConditionsCardiovascular Diseases

InterventionsN-3 Polyunsaturated Fatty Acids

DrugsN-3 Polyunsaturated Fatty Acids Placebo: Olive oil

Overview

Phase: Phase 3
Intervention: N-3 Polyunsaturated Fatty Acids
Conditions: Cardiovascular Diseases
Sponsor: Mario Negri Institute for Pharmacological Research
Enrollment: 12513
Locations: 1
Primary Endpoint: cardiovascular deaths and hospitalization for cardiovascular causes
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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:

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mario Negri Institute for Pharmacological Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Multiple risk factors:
•diabetes,
•age =\> 65 years,
•male sex,
•hypertension,
•hypercholesterolemia,
•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