Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
|ClinicalTrials.gov Identifier: NCT00317707|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : January 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Drug: N-3 Polyunsaturated Fatty Acids Drug: Placebo: Olive oil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12513 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||February 2004|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
|Experimental: N-3 PUFA||
Drug: N-3 Polyunsaturated Fatty Acids
Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
|Placebo Comparator: Olive oil||
Drug: Placebo: Olive oil
Each subject assigned to the control group will receive 1 g/day capsule of olive oil.
- cardiovascular deaths and hospitalization for cardiovascular causes [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317707
|Mario Negri Institute for Pharmacological Research|
|Milan, Italy, 20156|
|Study Chair:||Tombesi Massimo, MD||Centro Studi e Ricerca in Medicina Generale, Monza, Italy|
|Study Chair:||Tognoni Gianni, MD||Mario Negri Institute for Pharmacological Research, Milan, Italy|