MedTrace Logo

Observational Study of Cardiovascular Disease.

NCT04128475 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1137

Last updated 2024-04-08

No results posted yet for this study

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

Interventions

OTHER

N/A - observational study.

N/A - observational study.

Sponsors & Collaborators

  • The TIMI Study Group

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • University of Sydney

    lead OTHER

Principal Investigators

  • Anthony Keech · National Health and Medical Research Council, Australia

  • Peter Sever · Imperial College London

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • United States
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128475 on ClinicalTrials.gov