NCT04128475

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.

Trial Health

60
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,137

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

September 12, 2019

Last Update Submit

April 4, 2024

Conditions

Cardiovascular DiseasesCardiovascular MorbidityCoronary Heart DiseaseLow-density-lipoprotein-type

Keywords

Cardiovascular eventsCoronary heart diseaseCardiovascular deathLow density lipoprotein cholesterol (LDL-c)EvolocumabFOURIER OUTCOMES

Outcome Measures

Primary Outcomes (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.

    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 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.

    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.

    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.

    5 years

  • +3 more secondary outcomes

Interventions

N/A - observational study.OTHER

N/A - observational study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

TIMI Study Group

Boston, Massachusetts, 02115, United States

Location

Oslo University Hospital

Nydalen, Oslo County, 0424, Norway

Location

Imperial College London

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • Anthony Keech

    National Health and Medical Research Council, Australia

    STUDY CHAIR

  • Peter Sever

    Imperial College London

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

October 16, 2019

Study Start

February 5, 2020

Primary Completion

April 26, 2021

Study Completion

April 26, 2021

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)US(1)NO(1)