FOURIER LEGACY: Observational Study of Cardiovascular Disease.

Sponsor

University of Sydney (Other)

Overall Status

Recruiting

CT.gov ID

NCT04128475

Collaborator

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

10,000

Enrollment

Location

34.9

Anticipated Duration (Months)

286.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Cardiovascular Diseases Cardiovascular Morbidity Coronary Heart Disease Low-density-lipoprotein-type	Other: N/A - observational study.

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 5, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

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. [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

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 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 long-term effect of evolocumab treatment on CV death. [5 years]
To evaluate the long-term effect of evolocumab treatment on CV death.
To evaluate the long-term effects of evolocumab treatment on CHD death. [5 years]
To evaluate the long-term effects of evolocumab treatment on CHD death.
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 the individual components of the primary endpoint and any other CV hospitalizations.
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 on amputations and peripheral revascularization.
To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death). [5 years]
To evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
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 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 by baseline characteristics on defined study outcomes above. [5 years]
To assess the effect modification by baseline characteristics on defined study outcomes above.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.