Observational Study of Cardiovascular Disease.

Cardiovascular Diseases Clinical Trial

— FOURIER LEGACY  

Official title:

Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04128475
• Other study ID #: CTC0173
• Status: Terminated
• Start date: February 5, 2020
• Est. completion date: April 26, 2021

Study information

• Verified date: April 2024
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1137
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Morbidity
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Low-density-lipoprotein-type
• Myocardial Ischemia

Intervention

Other:
• N/A - observational study.
N/A - observational study.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Nydalen	Oslo
United Kingdom	Imperial College London	London
United States	TIMI Study Group	Boston	Massachusetts

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years
Secondary	To evaluate the long-term effect of evolocumab treatment on CV death.	To evaluate the long-term effect of evolocumab treatment on CV death.	5 years
Secondary	To evaluate the long-term effects of evolocumab treatment on CHD death.	To evaluate the long-term effects of evolocumab treatment on CHD death.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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).	5 years
Secondary	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.	5 years
Secondary	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.	5 years