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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 is a Phase 3 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 55 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03689946
The ClinicalTrials.gov registry entry for NCT03689946 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Evolocumab is the first listed.
NCT03689946 reports 0 study locations.
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.
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