Cardiovascular DiseasesPhase 3NCT00317707
Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk
A Phase 3 study testing N-3 Polyunsaturated Fatty Acids in people with Cardiovascular Diseases, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- N-3 Polyunsaturated Fatty Acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12,513 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2004to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple risk factors:
- diabetes,
- age => 65 years,
- male sex,
- hypertension,
- hypercholesterolemia,
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- N-3 Polyunsaturated Fatty Acids, Placebo: Olive oil
- Keywords
- cardiovascular risk, cardiovascular diseases, cardiovascular prevention, polyunsaturated fatty acids, diabetes, hypertension, hypercholesterolemia, obesity
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-3 Polyunsaturated Fatty AcidsDrug
Each subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA
Placebo: Olive oilDrug
Each subject assigned to the control group will receive 1 g/day capsule of olive oil.
| Study group | Role | What they receive |
|---|---|---|
| N-3 PUFA | Experimental | Not described Receives: Drug: N-3 Polyunsaturated Fatty Acids |
| Olive oil | Placebo comparator | Not described Receives: Drug: Placebo: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular deaths and hospitalization for cardiovascular causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startFeb 2004
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12,513 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tombesi Massimo, MD, Study chair, Centro Studi e Ricerca in Medicina Generale, Monza, ItalyTognoni Gianni, MD, Study chair, Mario Negri Institute for Pharmacological Research, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317707
- Sponsor's protocol ID
- R&P
- Status last verified
- Jan 2012
- First submitted
- 21 Apr 2006
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23656645Rischio 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.
PubMed 20509875
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00317707
- Acronym / sponsor ID
- R&P
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiovascular risk, cardiovascular diseases, cardiovascular prevention, polyunsaturated fatty acids, diabetes, hypertension, hypercholesterolemia, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,513 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-3 PUFA | Experimental | Drug: N-3 Polyunsaturated Fatty Acids |
| Olive oil | Placebo comparator | Drug: Placebo: Olive oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Multiple risk factors:
- Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack [TIA], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-3 Polyunsaturated Fatty AcidsEach subject assigned to active treatment group will receive 1g/day capsule of n-3 PUFA | Drug | N-3 PUFA |
| Placebo: Olive oilEach subject assigned to the control group will receive 1 g/day capsule of olive oil. | Drug | Olive oil |
Primary outcome
cardiovascular deaths and hospitalization for cardiovascular causes
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
- Derived from this study: PubMed 23656645Risk 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.
- Derived from this study: PubMed 20509875Rischio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tombesi Massimo, MD study chair
Centro Studi e Ricerca in Medicina Generale, Monza, Italy
Tognoni Gianni, MD study chair
Mario Negri Institute for Pharmacological Research, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-3 Polyunsaturated Fatty Acids in people with Cardiovascular Diseases, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular deaths and hospitalization for cardiovascular causes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.