Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    FOURIER Legacy
Previous Study | Return to List | Next Study

Observational Study of Cardiovascular Disease. (FOURIER LEGACY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128475
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
The Thrombolysis in Myocardial Infarction Study Group, Harvard University
Imperial College London
University of Oslo
Amgen
Information provided by (Responsible Party):
University of Sydney

Tracking Information
First Submitted Date September 12, 2019
First Posted Date October 16, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date February 5, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 13, 2019)
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. [ Time Frame: 5 years ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 13, 2019)
  • 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 ]
    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.
  • To evaluate the long-term effect of evolocumab treatment on CV death. [ Time Frame: 5 years ]
    To evaluate the long-term effect of evolocumab treatment on CV death.
  • To evaluate the long-term effects of evolocumab treatment on CHD death. [ Time Frame: 5 years ]
    To evaluate the long-term effects of evolocumab treatment on CHD death.
  • 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 the individual components of the primary endpoint and any other CV hospitalizations.
  • 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 on amputations and peripheral revascularization.
  • 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 evaluate the long-term effect of evolocumab treatment in terms of all-cause death (and non-CV, including cancer, death).
  • 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 of use or prescription lipid-lowering treatment classes (statins, cholesterol absorption inhibitors, PCSK9i) administered at FOURIER OUTCOMES trial entry on the outcomes above.
  • To assess the effect modification by baseline characteristics on defined study outcomes above. [ Time Frame: 5 years ]
    To assess the effect modification by baseline characteristics on defined study outcomes above.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Cardiovascular Disease.
Official Title Long-term Study of LDL-c Lowering With Evolocumab: Observational Follow-up After the FOURIER OUTCOMES Trial.
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants in selected countries who completed the FOURIER OUTCOMES trial, irrespective of non-fatal on-study events during FOURIER OUTCOMES trial, and who agree to take part in the FOURIER LEGACY study following study completion will be enrolled into this trial.
Condition
  • Cardiovascular Diseases
  • Cardiovascular Morbidity
  • Coronary Heart Disease
  • Low-density-lipoprotein-type
Intervention Other: N/A - observational study.
N/A - observational study.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 13, 2019)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2023
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: FOURIER Legacy 02 9562 5000 fourier.legacy@ctc.usyd.edu.au
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04128475
Other Study ID Numbers CTC0173
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Sydney
Study Sponsor University of Sydney
Collaborators
  • The Thrombolysis in Myocardial Infarction Study Group, Harvard University
  • Imperial College London
  • University of Oslo
  • Amgen
Investigators
Study Chair: Anthony Keech National Health and Medical Research Council, Australia
Study Chair: Peter Sever Imperial College London
PRS Account University of Sydney
Verification Date February 2020