Observational Study of Cardiovascular Disease.

Stopped early

Conditions studied: Cardiovascular Diseases, Cardiovascular Morbidity, Coronary Heart Disease, Low-density-lipoprotein-type

In brief

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.

Key facts

Study ID
NCT04128475
Run by
University of Sydney
People needed
1137
Starts
2020-02-05
Expected to finish
2021-04-26
Last updated by the study team
2024-04-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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