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

Mario Negri Institute for Pharmacological Research

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Drug: Placebo: Olive oil; Drug: N-3 Polyunsaturated Fatty Acids

Study type: Interventional

Funder types: Other

Identifiers

NCT00317707

R&P

Details and patient eligibility

About

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.

Enrollment: 12,513 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12,513 participants in 2 patient groups, including a placebo group

N-3 PUFA

Experimental group

Treatment:

Drug: N-3 Polyunsaturated Fatty Acids

Olive oil

Placebo Comparator group

Treatment:

Drug: Placebo: Olive oil