CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Evolocumab +5 moredrug
Likely dose
Evolocumab 140mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03689946
NCT03689946Phase 3Completed
CompareCT.gov

Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET: A Phase 3 Study

Cedars-Sinai Medical Center·interventional·Posted Oct 1, 2018·Updated Jul 17, 2024

In Brief

A Phase 3 clinical trial evaluating Evolocumab, 18F-NaF PET, and 4 other interventions for Cardiovascular Disease and Hyperlipidemia. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease, Hyperlipidemia
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartMar 19, 2019
Primary CompletionJan 28, 2023
Study CompletionMay 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.8 years ago

Interventions

Evolocumabdrug

Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously. Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.

18F-NaF PETother

18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.

CCTAother

CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.

Omnipaquedrug

contrast agent for CCTA

Metoprololdrug

beta blocker to optimize heart rate during CCTA

Nitroglycerindrug

premedication for CCTA