NCT00317707

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 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,513

participants targeted

Target at P75+ for phase_3 cardiovascular-diseases

Timeline
Completed

Started Feb 2004

Typical duration for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

7.7 years

First QC Date

April 21, 2006

Last Update Submit

January 17, 2012

Conditions

Cardiovascular Diseases

Keywords

cardiovascular riskcardiovascular diseasescardiovascular preventionpolyunsaturated fatty acidsdiabeteshypertensionhypercholesterolemiaobesity

Outcome Measures

Primary Outcomes (1)

  • cardiovascular deaths and hospitalization for cardiovascular causes

    5 years

Study Arms (2)

N-3 PUFA

EXPERIMENTAL
Drug: N-3 Polyunsaturated Fatty Acids

Olive oil

PLACEBO COMPARATOR
Drug: Placebo: Olive oil

Interventions

N-3 Polyunsaturated Fatty AcidsDRUG

Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA

N-3 PUFA
Placebo: Olive oilDRUG

Each subject assigned to the control group will receive 1 g/day capsule of olive oil.

Olive oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Negri Institute for Pharmacological Research

Milan, 20156, Italy

Location

Related Publications (2)

  • Risk and Prevention Study Collaborative Group; Roncaglioni MC, Tombesi M, Avanzini F, Barlera S, Caimi V, Longoni P, Marzona I, Milani V, Silletta MG, Tognoni G, Marchioli R. n-3 fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med. 2013 May 9;368(19):1800-8. doi: 10.1056/NEJMoa1205409.

    PMID: 23656645DERIVED

  • Rischio and Prevenzione Investigators. Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice. Trials. 2010 May 28;11:68. doi: 10.1186/1745-6215-11-68.

    PMID: 20509875DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusHypertensionHypercholesterolemiaObesity

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 25, 2006

Study Start

February 1, 2004

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

IT(1)