- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128475
Observational Study of Cardiovascular Disease. (FOURIER LEGACY)
Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial.
This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown.
Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: FOURIER Legacy
- Phone Number: 02 9562 5000
- Email: fourier.legacy@ctc.usyd.edu.au
Study Locations
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Oslo
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Nydalen, Oslo, Norway, 0424
- Oslo University Hospital
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London, United Kingdom
- Imperial College London
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Massachusetts
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Boston, Massachusetts, United States, 02115
- TIMI Study Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularisation in participants completing participation in the FOURIER OUTCOMES trial.
Time Frame: 5 years
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To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularization in patients completing participation in the FOURIER OUTCOMES trial.
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularization in patients completing participation in the FOURIER OUTCOMES trial.
Time Frame: 5 years
|
To evaluate the potential long-term effect of evolocumab treatment on a composite of CV death, MI, stroke or coronary revascularization in patients completing participation in the FOURIER OUTCOMES trial.
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5 years
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To evaluate the long-term effect of evolocumab treatment on CV death.
Time Frame: 5 years
|
To evaluate the long-term effect of evolocumab treatment on CV death.
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5 years
|
To evaluate the long-term effects of evolocumab treatment on CHD death.
Time Frame: 5 years
|
To evaluate the long-term effects of evolocumab treatment on CHD death.
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5 years
|
To evaluate the long-term effect of evolocumab treatment on the individual components of the primary endpoint and any other CV hospitalizations.
Time Frame: 5 years
|
To evaluate the long-term effect of evolocumab treatment on the individual components of the primary endpoint and any other CV hospitalizations.
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5 years
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To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization.
Time Frame: 5 years
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To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization.
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5 years
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To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
Time Frame: 5 years
|
To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
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5 years
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To assess the effect modification of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above.
Time Frame: 5 years
|
To assess the effect modification of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above.
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5 years
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To assess the effect modification by baseline characteristics on defined study outcomes above.
Time Frame: 5 years
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To assess the effect modification by baseline characteristics on defined study outcomes above.
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5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Anthony Keech, National Health and Medical Research Council, Australia
- Study Chair: Peter Sever, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTC0173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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