Status:
COMPLETED
Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mari...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12513 Patients enrolled
Trial Details
Trial ID
NCT00317707
Start Date
February 1 2004
End Date
October 1 2011
Last Update
January 18 2012
Active Locations (1)
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1
Mario Negri Institute for Pharmacological Research
Milan, Italy, 20156