Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
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|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|
|Actual Primary Completion Date :||October 2011|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|