NCT04128475

Observational Study of Cardiovascular Disease.

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,137 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	N/A - observational study.	N/A - observational study.

Timeline

• Start date: 2020-02-05
• Primary completion: 2021-04-26
• Completion: 2021-04-26
• First posted: 2019-10-16
• Last updated: 2024-04-08

Locations

3 sites across 3 countries: United States, Norway, United Kingdom