NCT00317707

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,513 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	N-3 Polyunsaturated Fatty Acids	Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
DRUG	Placebo: Olive oil	Each subject assigned to the control group will receive 1 g/day capsule of olive oil.

Timeline

• Start date: 2004-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2006-04-25
• Last updated: 2012-01-18

Locations

1 site across 1 country: Italy