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Observational Study of Cardiovascular Disease. (FOURIER LEGACY)

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ClinicalTrials.gov Identifier: NCT04128475
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
The Thrombolysis in Myocardial Infarction Study Group, Harvard University
Imperial College London
University of Oslo
Amgen
Information provided by (Responsible Party):
University of Sydney

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Cardiovascular Morbidity Coronary Heart Disease Low-density-lipoprotein-type Other: N/A - observational study.

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial.
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023
Groups and Cohorts
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Intervention Details:
  • Other: N/A - observational study.
    N/A - observational study.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 on amputations and peripheral revascularization.

  6. 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).

  7. 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.

  8. To assess the effect modification by baseline characteristics on defined study outcomes above. [ Time Frame: 5 years ]
    To assess the effect modification by baseline characteristics on defined study outcomes above.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128475


Contacts
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Contact: FOURIER Legacy 02 9562 5000 fourier.legacy@ctc.usyd.edu.au

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom
Contact: Judy Mackay       fourier.legacy@ctc.usyd.edu.au   
Sponsors and Collaborators
University of Sydney
The Thrombolysis in Myocardial Infarction Study Group, Harvard University
Imperial College London
University of Oslo
Amgen
Investigators
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Study Chair: Anthony Keech National Health and Medical Research Council, Australia
Study Chair: Peter Sever Imperial College London
More Information
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT04128475    
Other Study ID Numbers: CTC0173
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
Cardiovascular events
Coronary heart disease
Cardiovascular death
 Low density lipoprotein cholesterol (LDL-c)
Evolocumab
FOURIER OUTCOMES
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
 Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases