Observational Study of Cardiovascular Disease. (FOURIER LEGACY)

University of Sydney

Status: Terminated

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

Treatments: Other: N/A - observational study.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04128475

CTC0173

Details and patient eligibility

About

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.

Enrollment: 1,137 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.