Observational Study of Cardiovascular Disease.

University of Sydney1,137 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,137

Conditions

Cardiovascular Diseases Cardiovascular Morbidity Coronary Heart Disease Low-density-lipoprotein-type

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (3)

TIMI Study Group

Boston, Massachusetts, United States

Oslo University Hospital

Nydalen, Oslo, Norway

Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Time frame: 5 years

To evaluate the long-term effect of evolocumab treatment on CV death.

Time frame: 5 years

To evaluate the long-term effects of evolocumab treatment on CHD death.

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.

Time frame: 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 in terms of all-cause death (and non-CV, including cancer, death).

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.

Time frame: 5 years

To assess the effect modification by baseline characteristics on defined study outcomes above.

Time frame: 5 years