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NCT Number: NCT00317707

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

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mario Negri Institute for Pharmacological Research

Milan, 20156, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-3 Polyunsaturated Fatty Acids

Drug

Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA

Placebo: Olive oil

Drug

Each subject assigned to the control group will receive 1 g/day capsule of olive oil.

Primary outcomes

  1. cardiovascular deaths and hospitalization for cardiovascular causes

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Apr 25, 2006
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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