Observational Study of Cardiovascular Disease.

Terminated

• Conditions: Cardiovascular Morbidity; Cardiovascular Diseases; Coronary Heart Disease; Low-density-lipoprotein-type

• Registration Number: NCT04128475
• Lead Sponsor: University of Sydney

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-10-13
• Study First Posted: 2019-10-16
• Study Start: 2020-02-05
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1137

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.
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 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).

Trial Locations

Locations (3)

TIMI Study Group; 🇺🇸 Boston, Massachusetts, United States

Oslo University Hospital; 🇳🇴 Nydalen, Oslo, Norway

Imperial College London; 🇬🇧 London, United Kingdom