drugset / Trial / NCT03689946

Effect of Evolocumab on Coronary Atherosclerosis

NCT03689946

Phase 3 Completed 55 enrolled Cedars-Sinai Medical Center Amgen · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-03-19
Primary completion
2023-01-28
Completion
2023-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 140 mg Subcutaneous
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous
Background Iohexol Diagnostic / imaging agent
Background Metoprolol Other / unclassified
Background Nitroglycerin Unknown 0.4 mg Other
Background Nitroglycerin Unknown 0.8 mg Other