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NCT03689946 · ClinicalTrials.gov registry record · Phase 3
Effect of Evolocumab on Coronary Atherosclerosis
A Phase 3 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT03689946: Completed Phase 3 study, sponsored by Cedars-Sinai Medical Center.
NCT03689946 is a Phase 3 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689946, a Phase 3 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study will quantify changes in coronary plaque volumes and plaque composition in patients treated with evolocumab. Previous intravascular ultrasound studies have shown that treatment with a lipid-lowering PCSK9 enzyme inhibitor, such as evolocumab, to be associated with a reduction of the fatty deposits that cause plaque in the arteries, however, it is not known how evolocumab affects specific coronary plaque types and plaque inflammation. Investigators will use quantitative assessment of non-invasive coronary computed tomography angiography (CCTA) and positron emission tomography (PET)imaging to evaluate functional changes in plaque burden, plaque composition and vascular inflammation before and after treatment with evolocumab. Investigators propose to show that patients treated with evolocumab in combination with statins demonstrate a greater reduction of coronary non-calcified plaque volume, thereby reducing the number of future cardiac events.
Primary Outcome
Compare NCPV in mm\^3 measured on cardiac CT images as analyzed by quantitative software between the two assessments
Interventions
- DRUG Evolocumab
- DRUG Metoprolol
- DRUG Omnipaque
- DIAGNOSTIC_TEST CCTA
- DIAGNOSTIC_TEST 18F-NaF PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 3 |
What the finished NCT03689946 record still lists
NCT03689946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Evolocumab is the first listed.
NCT03689946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03689946 about?
NCT03689946 is a clinical study titled "Effect of Evolocumab on Coronary Atherosclerosis". This study will quantify changes in coronary plaque volumes and plaque composition in patients treated with evolocumab. Previous intravascular ultrasound studies have shown that treatment with a lipid-lowering PCSK9 enzyme inhibitor, such as evolocumab, to be associated with a reduction of the fatt...
What is the current status of trial NCT03689946?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2019-03-19. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT03689946?
The interventions under investigation include: Evolocumab (DRUG), Metoprolol (DRUG), Omnipaque (DRUG), CCTA (DIAGNOSTIC_TEST), 18F-NaF PET (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03689946?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03689946's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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