Observational Study of Cardiovascular Disease. (FOURIER LEGACY)

April 4, 2024 updated by: University of Sydney

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

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oslo
      • Nydalen, Oslo, Norway, 0424
        • Oslo University Hospital
  • United Kingdom
      • London, United Kingdom
        • Imperial College London
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • TIMI Study Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
5 years

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.
5 years
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.
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.
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.
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 on amputations and peripheral revascularization.
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 evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
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 of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

University of Oslo
Imperial College London
Amgen
The Thrombolysis in Myocardial Infarction Study Group, Harvard University

Investigators

  • Study Chair: Anthony Keech, National Health and Medical Research Council, Australia
  • Study Chair: Peter Sever, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

September 12, 2019

First Submitted That Met QC Criteria

October 13, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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