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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
12,513
Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
Each subject assigned to the control group will receive 1 g/day capsule of olive oil.
Mario Negri Institute for Pharmacological Research
Milan, Italy
cardiovascular deaths and hospitalization for cardiovascular causes
Time frame: 5 years
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