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NCT04128475 · ClinicalTrials.gov registry record
Observational Study of Cardiovascular Disease.
A clinical trial, sponsored by University of Sydney.
- Terminated
- Registry status
- 1,137
- Enrollment target
NCT04128475: Clinical Trial study, sponsored by University of Sydney.
NCT04128475 is a clinical trial that was terminated before completion, run by University of Sydney. The registered enrollment target is 1,137 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128475 was terminated before completion, sponsored by University of Sydney.
- TERMINATED
- Registry status
- 1,137 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER N/A - observational study.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,137 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2021-04-26 |
Why NCT04128475 stopped before completion
NCT04128475 is an observational study that tracks outcomes without assigning an intervention. Its 1,137 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which N/A - observational study. is the first listed.
NCT04128475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04128475 about?
NCT04128475 is a clinical study titled "Observational Study of Cardiovascular Disease.". 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 simi...
What is the current status of trial NCT04128475?
This trial is currently terminated. The enrollment target is 1,137 participants. The study started on 2020-02-05. Estimated completion is 2021-04-26.
What interventions are being tested in trial NCT04128475?
The interventions under investigation include: N/A - observational study. (OTHER).
Who is sponsoring clinical trial NCT04128475?
This trial is sponsored by University of Sydney, which has 9 total clinical trials registered on ClinicalTrials.gov.
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