Cardiovascular DiseasesFOURIER LEGACYNCT04128475
Observational Study of Cardiovascular Disease.
An observational study of Cardiovascular Diseases and Cardiovascular Morbidity, run by University of Sydney at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Morbidity, Coronary Heart Disease
- What is being tested?
- N/A - observational study.
- How many people
- 1,137 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Feb 2020to 26 Apr 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial.
Subjects who completed the FOURIER OUTCOMES trial (defined as attendance at close-out visit irrespective of treatment compliance) will be approached by FOURIER OUTCOMES site investigators and asked about their interest in taking part in this trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases, Cardiovascular Morbidity, Coronary Heart Disease, Low-density-lipoprotein-type
- Being tested
- N/A - observational study.
- Keywords
- Cardiovascular events, Coronary heart disease, Cardiovascular death, Low density lipoprotein cholesterol (LDL-c), Evolocumab, FOURIER OUTCOMES
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A - observational study.Other
N/A - observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 5 years
Secondary outcomes (8)
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.
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.
Measured: 5 years
To evaluate the long-term effect of evolocumab treatment on CV death.
To evaluate the long-term effect of evolocumab treatment on CV death.
Measured: 5 years
To evaluate the long-term effects of evolocumab treatment on CHD death.
To evaluate the long-term effects of evolocumab treatment on CHD death.
Measured: 5 years
To evaluate the long-term effect of evolocumab treatment on the individual components of the primary endpoint and any other CV hospitalizations.
To evaluate the long-term effect of evolocumab treatment on the individual components of the primary endpoint and any other CV hospitalizations.
Measured: 5 years
To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization.
To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization.
Measured: 5 years
To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
Measured: 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.
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.
Measured: 5 years
To assess the effect modification by baseline characteristics on defined study outcomes above.
To assess the effect modification by baseline characteristics on defined study outcomes above.
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 posted16 Oct 2019
- Study start5 Feb 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Why it stopped: Withdrawal of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- The TIMI Study Group, Imperial College London, University of Oslo, Amgen
- Responsible party
- Sponsor
- Investigators
- Anthony Keech, Study chair, National Health and Medical Research Council, AustraliaPeter Sever, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128475
- Sponsor's protocol ID
- CTC0173
- Acronym
- FOURIER LEGACY
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2019
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial.
- ClinicalTrials.gov ID
- NCT04128475
- Acronym / sponsor ID
- FOURIER LEGACY / CTC0173
- Conditions
- Cardiovascular Diseases, Cardiovascular Morbidity, Coronary Heart Disease, Low-density-lipoprotein-type
- Keywords
- Cardiovascular events, Coronary heart disease, Cardiovascular death, Low density lipoprotein cholesterol (LDL-c), Evolocumab, FOURIER OUTCOMES
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Withdrawal of funding.
- Enrolment
- 1,137 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- The TIMI Study Group, Imperial College London, University of Oslo, Amgen
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 16 Oct 2019 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial.
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/A - observational study.N/A - observational study. | Other | – |
Primary outcome
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
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.
8 secondary outcomes
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 long-term effect of evolocumab treatment on CV death.
Time frame: 5 years
To evaluate the long-term effects of evolocumab treatment on CHD death.
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.
Time frame: 5 years
To evaluate the long-term effect of evolocumab treatment on amputations and peripheral revascularization.
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).
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.
Time frame: 5 years
To assess the effect modification by baseline characteristics on defined study outcomes above.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Withdrawal of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Anthony Keech study chair
National Health and Medical Research Council, Australia
Peter Sever study chair
Imperial College London
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Morbidity, run by University of Sydney at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Norway, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Withdrawal of funding.). Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024.